DECLARACIÓN DE CONFORMIDAD · 31. F0817, Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/ FITC...

Ministerio de Salud

Secretaria de Calidad en SaludA.N.M.A.T.

"2020 - AÑO DEL GENERAL MANUEL BELGRANO"

DECLARACIÓN DE CONFORMIDAD

En nombre y representación de la firma Tecnolab S.A., declaramos bajo juramento, en lostérminos previstos por la Disposición ANMAT N° 2275/06, que los Productos Médicos paraDiagnóstico de Uso In-Vitro cuyos datos identificatorios y demás características se detallan acontinuación, CUMPLEN los requisitos técnicos previstos en el Anexo I de la Disposición ANMATN° 2674/99 , conservándose la documentación respaldatoria a disposición de las autoridades enel domicilio de la empresa.

Número de PM:

1252-181

Nombre técnico del producto:

17-093 - Reactivos para Inmunodiagnóstico

Nombre comercial:

LISTADO DE ANTICUERPOS MONOCLONALES Y POLICLONALES PARAINMUNODIAGNÓSTICO MULTIPARAMÉTRICO.

Modelos:

1. C7066, Monoclonal Mouse Anti-Human CD19/RPE-Cy5 Clone HD37, 1mL2. C7067, Monoclonal Mouse Anti-Human CD3/RPE-Cy5 Clone UCHT1, 1mL3. C7099, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE-Cy5 CloneT29/33, 1mL4. C7224, Monoclonal Mouse Anti-Human CD19/APC Clone HD37, 1mL5. C7225, Monoclonal Mouse Anti-Human CD3/APC Clone UCHT1, 1mL6. C7226, Monoclonal Mouse Anti-Human CD4/APC Clone MT310, 1mL7. C7227, Monoclonal Mouse Anti-Human CD8/APC Clone DK25, 1mL8. C7230, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/APC Clone

Página 1 de 16PM Número: 1252-181 Página 1 de 16

El presente documento electrónico ha sido firmado digitalmente en los términos de la Ley N° 25.506, el Decreto N° 2628/2002 y el Decreto N° 283/2003.-

T29/33, 1mL9. C7238, Monoclonal Mouse Anti-Human CD34 Class III/APC Clone BIRMA-K3, 0.5mL10. C7242, Monoclonal Mouse Anti-Human CD5/APC Clone DK23, 1mL11. C7244, Monoclonal Mouse Anti-Human CD117, c-kit/APC Clone 104D2, 1mL12. C7246, Monoclonal Mouse Anti-Human Myeloperoxidase/APC Clone MPO-7, 1mL13. C7252, Monoclonal Mouse Anti-Human CD79acy/APC Clone HM57, 1mL14. C7256, Monoclonal Mouse Anti-Human CD138/APC Clone MI15, 1mL15. C7278, Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/APC Clone 10.1, 1mL16. C7280, Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/APC Clone Y2/51,1mL17. C7281, Monoclonal Mouse Anti-Human CD22/APC Clone 4KB128, 1mL18. F0713, Monoclonal Mouse Anti-Human CD11c, Protein 150,95/ FITC Clone KB90, 1mL19. F0714, Monoclonal Mouse Anti-Human Myeloperoxidase/FITC Clone MPO-7, 1mL20. F0765, Monoclonal Mouse Anti-Human CD8/FITC Clone DK25, 1mL21. F0766, Monoclonal Mouse Anti-Human CD4/FITC Clone MT310, 1mL22. F0767, Monoclonal Mouse Anti-Human CD2/FITC Clone MT910, 1mL23. F0768, Monoclonal Mouse Anti-Human CD19/FITC Clone HD37, 1mL24. F0788, Monoclonal Mouse Anti-Human Ki-67 Antigen/FITC Clone Ki-67, 1mL25. F0789, Monoclonal Mouse Anti-Human CD7/FITC Clone DK24, 1mL26. F0795, Monoclonal Mouse Anti-Human CD5/FITC Clone DK23, 1mL27. F0799, Monoclonal Mouse Anti-Human CD20/FITC Clone B-Ly1, 1mL28. F0800, Monoclonal Mouse Anti-Human CD45R0/FITC Clone UCHL1, 1mL29. F0801, Monoclonal Mouse Anti-Human CD25, Interleukin-2 Receptor/FITC Clone ACT-1, 1mL30. F0803, Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/FITC Clone Y2/51,1mL31. F0817, Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/ FITC Clone CR3/43, 1mL32. F0818, Monoclonal Mouse Anti-Human CD3/FITC Clone UCHT1, 1mL33. F0826, Monoclonal Mouse Anti-Human CD10/FITC Clone SS2/36, 1mL34. F0829, Monoclonal Mouse Anti-Human CD71, Transferrin Receptor/FITC Clone Ber-T9, 1mL35. F0830, Monoclonal Mouse Anti-Human CD15/FITC Clone C3D-1, 1mL36. F0831, Monoclonal Mouse Anti-Human CD13/FITC Clone WM-47, 1mL37. F0832, Monoclonal Mouse Anti-Human CD33/FITC Clone WM-54, 1mL38. F0844, Monoclonal Mouse Anti-Human CD14/FITC Clone TÜK4, 1mL39. F0849, Monoclonal Mouse Anti-Human CD30/FITC Clone Ber-H2, 1mL40. F0860, Monoclonal Mouse Anti-Human Epithelial Antigen/FITC Clone Ber-EP4, 1mL41. F0861, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/FITC CloneT29/33, 1mL42. F0870, Monoclonal Mouse Anti-Human CD235a, Glycophorin A/ FITC Clone JC159, 1mL43. F7011, Monoclonal Mouse Anti-Human CD16, Fc Gamma Receptor III/FITC Clone DJ130c,1mL44. F7060, Monoclonal Mouse Anti-Human CD22/FITC Clone 4KB128, 1mL45. F7062, Monoclonal Mouse Anti-Human CD23/FITC Clone MHM6, 1mL46. F7081, Monoclonal Mouse Anti-Human CD34 Class III/FITC Clone BIRMA-K3, 1mL47. F7088, Monoclonal Mouse Anti-Human CD41, Platelet Glycoprotein IIb/FITC Clone 5B12,1mL48. F7101, Monoclonal Mouse Anti-Human CD38/FITC Clone AT13/5, 1mL49. F7102, Monoclonal Mouse Anti-Human CD43/FITC Clone DF-T1, 1mL50. F7110, Monoclonal Mouse Anti-Human B Cell/FITC Clone FMC7, 1mL51. F7112, Monoclonal Mouse Anti-Human CD66abce/FITC Clone Kat4c, 1mL52. F7134, Monoclonal Mouse Anti-Human CD24/FITC Clone SN3, 1mL53. F7135, Monoclonal Mouse Anti-Human CD68/FITC Clone KP1, 1mL



54. F7137, Monoclonal Mouse Anti-Human CD79ß/FITC Clone SN8, 1mL55. F7138, Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocyte Antigen/FITC Clone Ber-ACT8, 1mL56. F7139, Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/FITC CloneHT-6, 0.5mL57. F7141, Monoclonal Mouse Anti-Human CD1a/FITC Clone NA1/34, 1mL58. F7149, Monoclonal Mouse Anti-Human Plasma Cell/FITC Clone VS38c, 1mL59. F7266, Monoclonal Mouse Anti-Human HLA-DR Antigen/FITC Clone AB3, 1mL60. F7270, Monoclonal Mouse Anti-Human CD57/FITC Clone TB01, 1mL61. F7276, Monoclonal Mouse Anti-Human CD7/FITC Clone CBC.37, 1mL62. GA051 , FLEX Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone34BE12, Ready-to-Use (Dako Omnis), 12mL63. GA052 , FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB45, Ready-to-Use(Dako Omnis), 12mL64. GA053 , FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, Ready-to-Use(Dako Omnis), 12mL65. GA059 , FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use(Dako Omnis), 12mL66. GA060 , FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4, Ready-to-Use (DakoOmnis), 12mL67. GA062, FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (DakoOmnis), 12mL68. GA074, FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, Ready-to-Use(Dako Omnis), 12mL69. GA075 , FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314,Ready-to-Use (Dako Omnis), 12mL70. GA077 , FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone23A3, Ready-to-Use (Dako Omnis), 12mL71. GA080 , FLEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2,Ready-to-Use (DakoOmnis), 12mL72. GA083 , FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (DakoOmnis), 12mL73. GA054, FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (DakoOmnis), 12mL74. GA058, FLEX Monoclonal Mouse Anti-Human Inhibin a Clone R1 Ready-to-Use (DakoOmnis), 12mL75. GA067, FLEX Monoclonal Mouse Anti-Myogenin Clone F5D Ready-to-Use (Dako Omnis),12mL76. GA084, FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), 12mL77. GA090, FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294,Ready-to-Use (Dako Omnis), 12mL78. GA602, FLEX Monoclonal Mo a Hu CD30, Clone Ber-H2, RTU (Dako Omnis), 12mL79. GA604, FLEX Monoclonal Mouse Anti-Human CD20cy Clone L26 Ready-to-Use (DakoOmnis), 12mL80. GA605, FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (DakoOmnis), 12mL81. GA607, FLEX Monoclonal Mouse Anti-Human Neurofilament Protein Clone 2F11 Ready-to-Use (Dako Omnis), 12mL82. GA609, FLEX Monoclonal Mouse Anti-Human CD68 Clone KP1 Ready-to-Use (Dako Omnis),12mL



83. GA610, FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A Ready-to-Use (Dako Omnis), 12mL84. GA611, FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Dako Omnis), 12mL85. GA613, FLEX Monoclonal Mouse Anti-Human CD68 Clone PG-M1 Ready-to-Use (DakoOmnis), 12mL86. GA615, FLEX Monoclonal Mouse Anti-Human Cytokeratin 19 Clone RCK108 Ready-to-Use(Dako Omnis), 12mL87. GA616, FLEX Monoclonal Mouse Anti-Human p53 Protein Clone DO-7 Ready-to-Use (DakoOmnis), 12mL88. GA618, FLEX Monoclonal Mouse Anti-Human Cytokeratin 18 Clone DC 10 Ready-to-Use(Dako Omnis), 12mL89. GA619, FLEX Monoclonal Mouse Anti-Human Cytokeratin 7 Clone OV-TL 12/30 Ready-to-Use (Dako Omnis), 12mL90. GA621, FLEX Monoclonal Mouse Anti-Human CD79a Clone JCB117 Ready-to-Use (DakoOmnis), 12mL91. GA622, FLEX Monoclonal Mouse Anti-Human Carcinoembryonic Antigen Clone II-7 Ready-to-Use (Dako Omnis), 12mL92. GA623, FLEX Monoclonal Mouse Anti-Human CD8 Clone C8/144B Ready-to-Use (DakoOmnis), 12mL93. GA624, FLEX Monoclonal Mouse Anti-Human Hepatocyte Clone OCH1E5 Ready-to-Use(Dako Omnis), 12mL94. GA625, FLEX Monoclonal Mouse Anti-Human BCL6 Protein Clone PG-B6p Ready-to-Use(Dako Omnis), 12mL95. GA626, FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen Clone MIB-1 Ready-to-Use(Dako Omnis), 12mL96. GA629, FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29,Ready-to-Use (Dako Omnis), 12mL97. GA630, FLEX Monoclonal Mouse Anti- Vimentin Clone V9 Ready-to-Use (Dako Omnis), 12mL98. GA632, FLEX Monoclonal Mouse Anti-Human CD34 Class II Clone QBEnd 10 Ready-to-Use(Dako Omnis), 12mL99. GA636, FLEX Monoclonal Mouse Anti-Human CD43 Clone DF-T1 Ready-to-Use (DakoOmnis), 12mL100. GA637, FLEX Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 Ready-to-Use (Dako Omnis), 12mL101. GA641, FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK1 Ready-to-Use (Dako Omnis), 12mL102. GA642, FLEX Monoclonal Mouse Anti-Human CD138 Clone MI15 Ready-to-Use (DakoOmnis), 12mL103. GA643, FLEX Monoclonal Mouse Anti-Human CD7 Clone CBC.37 Ready-to-Use (DakoOmnis), 12mL104. GA644, FLEX Monoclonal Mouse Anti-Human MUM1 Protein Clone MUM1p Ready-to-Use(Dako Omnis), 12mL105. GA647, FLEX Monoclonal Mouse Anti-Human CD57, Clone TB01, Ready-to-Use (DakoOmnis), 12mL106. GA648, FLEX Monoclonal Mouse Anti-Human CD10 Clone 56C6 Ready-to-Use (DakoOmnis), 12mL107. GA650, FLEX Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein Clone DAK-Pax5 Ready-to-Use (Dako Omnis), 12mL108. GA651, FLEX Monoclonal Mouse Anti-Human CD2 Clone AB75 Ready-to-Use (DakoOmnis), 12mL



109. GA652, FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use(Dako Omnis), 12mL110. GA656, FLEX Monoclonal Mouse Anti-Human CD19, Clone LE-CD19, Ready-to-Use (DakoOmnis), 12mL111. GA659, FLEX Monoclonal Rabbit Anti-Human ERG Clone EP111 Ready-to-Use (DakoOmnis), 12mL112. GA660, FLEX Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP, RTU(Dako Omnis), 12mL113. GA662, FLEX Monoclonal Mouse Anti-Human p63 Protein, Clone DAK-p63, Ready-to-Use(Dako Omnis), 12mL114. GA701, FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11 Ready-to-Use (DakoOmnis), 12mL115. GA702, FLEX Monoclonal Mouse Anti-Human Beta-Catenin Clone ß-Catenin-1 Ready-to-Use (Dako Omnis), 12mL116. GA751, FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen Clones2B11 + PD7/26 Ready-to-Use (Dako Omnis), 12mL117. GA777, FLEX Monoclonal Mouse Anti-Human Cytokeratin 20 Clone Ks20.8 Ready-to-Use(Dako Omnis), 12mL118. GA780, FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6 Clone D5/16 B4 Ready-to-Use (Dako Omnis), 12mL119. GA781, FLEX Monoclonal Mouse Anti-Human CD23 Clone DAK-CD23 Ready-to-Use (DakoOmnis), 12mL120. IR602, FLEX Monoclonal Mouse Anti-Human CD30 Clone Ber-H2 Ready-to-Use (Link), 40-60 Tests121. IR604, FLEX Monoclonal Mouse Anti-Human CD20cy Clone L26 Ready-to-Use (Link), 40-60Tests122. IR605, FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Link), 40-60 Tests123. IR606, FLEX Monoclonal Mouse Anti-Human Desmin Clone D33 Ready-to-Use (Link), 40-60Tests124. IR607, FLEX Monoclonal Mouse Anti-Human Neurofilament Protein Clone 2F11 Ready-to-Use (Link), 40-60 Tests125. IR608, FLEX Monoclonal Mouse Anti-Human CD21 Clone 1F8 Ready-to-Use (Link), 40-60Tests126. IR609, FLEX Monoclonal Mouse Anti-Human CD68 Clone KP1 Ready-to-Use (Link), 40-60Tests127. IR610, FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A Ready-to-Use (Link), 40-60 Tests128. IR611, FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin Clone 1A4 Ready-to-Use(Link), 40-60 Tests129. IR612, FLEX Monoclonal Mouse Anti-Human Neuron-Specific Enolase Clone BBS/NC/VI-H14 Ready-to-Use (Link), 40-60 Tests130. IR613, FLEX Monoclonal Mouse Anti-Human CD68 Clone PG-M1 Ready-to-Use (Link), 40-60 Tests131. IR614, FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein Clone 124 Ready-to-Use(Link), 40-60 Tests132. IR615, FLEX Monoclonal Mouse Anti-Human Cytokeratin 19 Clone RCK108 Ready-to-Use(Link), 40-60 Tests133. IR616, FLEX Monoclonal Mouse Anti-Human p53 Protein Clone DO-7 Ready-to-Use (Link),40-60 Tests134. IR618, FLEX Monoclonal Mouse Anti-Human Cytokeratin 18 Clone DC 10 Ready-to-Use



(Link), 40-60 Tests135. IR619, FLEX Monoclonal Mouse Anti-Human Cytokeratin 7 Clone OV-TL 12/30 Ready-to-Use (Link), 40-60 Tests136. IR620, FLEX Monoclonal Mouse Anti- Cytokeratin 17 Clone E3 Ready-to-Use (Link), 40-60Tests137. IR621, FLEX Monoclonal Mouse Anti-Human CD79a Clone JCB117 Ready-to-Use (Link),40-60 Tests138. IR622, FLEX Monoclonal Mouse Anti-Human Carcinoembryonic Antigen Clone II-7 Ready-to-Use (Link), 40-60 Tests139. IR623, FLEX Monoclonal Mouse Anti-Human CD8 Clone C8/144B Ready-to-Use (Link), 40-60 Tests140. IR624, FLEX Monoclonal Mouse Anti-Human Hepatocyte Clone OCH1E5 Ready-to-Use(Link), 40-60 Tests141. IR625, FLEX Monoclonal Mouse Anti-Human BCL6 Protein Clone PG-B6p Ready-to-Use(Link), 40-60 Tests142. IR626, FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen Clone MIB-1 Ready-to-Use(Link), 40-60 Tests143. IR627, FLEX Monoclonal Mouse Anti-Human Calretinin Clone DAK-Calret 1 Ready-to-Use(Link), 40-60 Tests144. IR628, FLEX Monoclonal Mouse Anti-Human CD56 Clone 123C3 Ready-to-Use (Link), 40-60 Tests145. IR629, FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen Clone E29Ready-to-Use (Link), 40-60 Tests146. IR630, FLEX Monoclonal Mouse Anti- Vimentin Clone V9 Ready-to-Use (Link), 40-60 Tests147. IR632, FLEX Monoclonal Mouse Anti-Human CD34 Class II Clone QBEnd 10 Ready-to-Use(Link), 40-60 Tests148. IR633, FLEX Monoclonal Mouse Anti-Human Melan-A Clone A103 Ready-to-Use (Link), 40-60 Tests149. IR635, FLEX Monoclonal Mouse Anti- Pneumocystis Jiroveci Clone 3F6 Ready-to-Use(Link), 40-60 Tests150. IR636, FLEX Monoclonal Mouse Anti-Human CD43 Clone DF-T1 Ready-to-Use (Link), 40-60Tests151. IR637, FLEX Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 Ready-to-Use (Link), 40-60 Tests152. IR640, FLEX Monoclonal Mouse Anti-Human Mast Cell Tryptase Clone AA1 Ready-to-Use(Link), 40-60 Tests153. IR641, FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK1 Ready-to-Use (Link), 40-60 Tests154. IR642, FLEX Monoclonal Mouse Anti-Human CD138 Clone MI15 Ready-to-Use (Link), 40-60Tests155. IR643, FLEX Monoclonal Mouse Anti-Human CD7 Clone CBC.37 Ready-to-Use (Link), 40-60 Tests156. IR644, FLEX Monoclonal Mouse Anti-Human MUM1 Protein Clone MUM1p Ready-to-Use(Link), 40-60 Tests157. IR647, FLEX Monoclonal Mouse Anti-Human CD57 Clone TB01 Ready-to-Use (Link), 40-60Tests158. IR648, FLEX Monoclonal Mouse Anti-Human CD10 Clone 56C6 Ready-to-Use (Link), 40-60Tests159. IR649, FLEX Monoclonal Mouse Anti-Human CD4 Clone 4B12 Ready-to-Use (Link), 40-60Tests160. IR650, FLEX Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein Clone DAK-



Pax5 Ready-to-Use (Link), 40-60 Tests161. IR651, FLEX Monoclonal Mouse Anti-Human CD2 Clone AB75 Ready-to-Use (Link), 40-60Tests162. IR652, FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use(Link), 40-60 Tests163. IR653, FLEX Monoclonal Mouse Anti-Human ZAP-70 Clone 2F3.2 Ready-to-Use (Link), 40-60 Tests164. IR656, FLEX Monoclonal Mouse Anti-Human CD19 Clone LE-CD19 Ready-to-Use (Link),40-60 Tests165. IR657, FLEX Monoclonal Mouse Anti-Human Estrogen Receptor a Clone 1D5 Ready-to-Use(Link), 40-60 Tests166. IR658, FLEX Monoclonal Mouse Anti-Human MUC2 Clone CCP58 Ready-to-Use (Link), 40-60 Tests167. IR659, FLEX Monoclonal Rabbit Anti-Human ERG Clone EP111 Ready-to-Use (Link), 40-60Tests168. IR660, FLEX Monoclonal Mouse Anti-Human Synaptophysin Clone DAK-SYNAP Ready-to-Use (Link), 40-60 Tests169. IR661, FLEX Monoclonal Mouse Anti-Human MUC5AC Clone CLH2 Ready-to-Use (Link),40-60 Tests170. IR662, FLEX Monoclonal Mouse Anti-Human p63 Protein Clone DAK-p63 Ready-to-Use(Link), 40-60 Tests171. IR700, FLEX Monoclonal Mouse Anti-Human Muscle Actin Clone HHF35 Ready-to-Use(Link), 40-60 Tests172. IR701, FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11 Ready-to-Use (Link), 40-60Tests173. IR702, FLEX Monoclonal Mouse Anti-Human Beta-Catenin Clone ß-Catenin-1 Ready-to-Use(Link), 40-60 Tests174. IR751, FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen Clones2B11 + PD7/26 Ready-to-Use (Link), 40-60 Tests175. IR753, FLEX Monoclonal Mouse Anti- Epstein-Barr Virus, LMP Clones CS.1-4 Ready-to-Use(Link), 40-60 Tests176. IR777, FLEX Monoclonal Mouse Anti-Human Cytokeratin 20 Clone Ks20.8 Ready-to-Use(Link), 40-60 Tests177. IR779, FLEX Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase Clone 8A9Ready-to-Use (Link), 40-60 Tests178. IR780, FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6 Clone D5/16 B4 Ready-to-Use(Link), 40-60 Tests179. IR781, FLEX Monoclonal Mouse Anti-Human CD23 Clone DAK-CD23 Ready-to-Use (Link),40-60 Tests180. IR051 , FLEX Monoclonal Mouse Anti-Human Cytokeratin High Molecular Weight, Clone34BE12, Ready-to-Use (Link), 40-60 Tests181. IR052 , FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB45, Ready-to-Use(Link), 40-60 Tests182. IR053 , FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3,Ready-to-Use(Link), 40-60 Tests183. IR054 , FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Link),40-60 Tests184. IR055 , FLEX Monoclonal Mouse Anti-Human Wilms Tumor 1 (WT1) Protein, Clone 6F-H2,Ready-to-Use (Link), 40-60 Tests185. IR056 , FLEX Monoclonal Mouse Anti-Thyroid Transcription Factor, Clone 8G7G3/1, Ready-to-Use (Link), 40-60 Tests



186. IR057 , FLEX Monoclonal Mouse Anti-Human CD99, MIC2 Gene Product, Ewing’s SarcomaMarker, Clone 12E7, Ready-to-Use (Link), 40-60 Tests187. IR058 , FLEX Monoclonal Mouse Anti-Human Inhibin alpha, Clone R1, Ready-to-Use (Link),40-60 Tests188. IR059 , FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use(Link), 40-60 Tests189. IR060 , FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4, Ready-to-Use (Link),40-60 Tests190. IR061 , FLEX Monoclonal Mouse Anti-Human Tyrosinase, Clone T311, Ready-to-Use (Link),40-60 Tests191. IR062 , FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (Link), 40-60 Tests192. IR066, FLEX Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain, CloneSMMS-1, Ready-to-Use (Link), 40-60 Tests193. IR067 , FLEX Monoclonal Mouse Anti-Myogenin, Clone F5D, Ready-to-Use (Link), 40-60Tests194. IR068 , FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636,Ready-to-Use (Link), 40-60 Tests195. IR069 , FLEX Monoclonal Mouse Anti-Human CD1a, Clone 010, Ready-to-Use (Link), 40-60Tests196. IR072 , FLEX Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40, Ready-to-Use(Link), 40-60 Tests197. IR074 , FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, Ready-to-Use(Link), 40-60 Tests198. IR075 , FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, CloneSPM314, Ready-to-Use (Link), 40-60 Tests199. IR076 , FLEX Monoclonal Mouse Anti-Villin, Clone 1D2 C3, Ready-to-Use (Link), 40-60Tests200. IR077 , FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone23A3, Ready-to-Use (Link), 40-60 Tests201. IR079 , FLEX Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, Ready-to-Use (Link), 40-60 Tests202. IR080 , FLEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2, Ready-to-Use(Link), 40-60 Tests203. IR082 , FLEX Monoclonal Mouse Anti-Human CD5, Clone 4C7, Ready-to-Use (Link), 40-60Tests204. IR083 , FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Link),40-60 Tests205. IR084 , FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor alpha, Clone EP1, Ready-to-Use (Link), 40-60 Tests206. IR085 , FLEX Monoclonal Mouse Anti-Human MutS Protein Homolog 2, Clone FE11, Ready-to-Use (Link), 40-60 Tests207. IR086 , FLEX Monoclonal Rabbit Anti-Human MutS Protein Homolog 6, Clone EP49, Ready-to-Use (Link), 40-60 Tests208. IR087 , FLEX Monoclonal Rabbit Anti-Human Postmeiotic Segregation Increased 2, CloneEP51, Ready-to-Use (Link), 40-60 Tests209. IR088 , FLEX Monoclonal Mouse Anti-Human Prostein, Clone 10E3, Ready-to-Use (Link),40-60 Tests210. IR089 , FLEX Monoclonal Mouse Anti-Human Prostate Specific Membrane Antigen, Clone3E6, Ready-to-Use (Link), 40-60 Tests211. IR091 , FLEX Monoclonal Mouse Anti-Human ERCC1, Clone 4F9, Ready-to-Use (Link), 40-



60 Tests212. IR092 , FLEX Monoclonal Mouse Anti-Human Octamer-binding Transcription Factor 3/4,Ready-to-Use (Link), 40-60 Tests213. IR093 , FLEX Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, CloneEP266, Ready-to-Use (Link), 40-60 Tests214. IR094, FLEX Monoclonal Rabbit Anti-Human Cytokeratin 8/18, Clone EP17/EP30, Ready-to-Use (Link), 40-60 Tests215. M0617 , Monoclonal Mouse Anti-Thrombomodulin, Clone 1009, 1mL216. M0630 , Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BE12,1mL217. M0634 , Monoclonal Mouse Anti-Human Melanosome, Clone HMB45, 1mL218. M0635 , Monoclonal Mouse Anti-Human Muscle Actin, Clone HHF35, 1mL219. M0638 , Monoclonal Mouse Anti-Human Laminin, Clone 4C7, 1mL220. M3501 , Monoclonal Mouse Anti-Adrenocorticotropin (ACTH), Clone 02A3, 1mL221. M3502 , Monoclonal Mouse Anti-Human Luteinizing Hormone (LH), Clone C93, 1mL222. M3503 , Monoclonal Mouse Anti-Human Thyroid-Stimulating Hormone (TSH), Clone 0042,1mL223. M3504 , Monoclonal Mouse Anti-Human Follicle-Stimulating Hormone (FSH), Clone C10,1mL224. M3505 , Monoclonal Mouse Anti-Human Mesothelial Cell, Clone HBME-1, 1mL225. M3512 , Monoclonal Mouse Anti-Human MyoD1, Clone 5.8A, 1mL226. M3515 , Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, 1mL227. M3517 , Monoclonal Mouse Anti-CA 19-9, Clone 116-NS-19-9, 1mL228. M3525 , Monoclonal Mouse Anti-Human Epithelial-Related Antigen, Clone MOC-31, 1mL229. M3539 , Monoclonal Mouse Anti-Human Beta-Catenin, Clone B-Catenin-1, 1mL230. M3556 , Monoclonal Mouse Anti-Human Calponin, Clone CALP, 1mL231. M3562 , Monoclonal Mouse Anti-Human Androgen Receptor, Clone AR441, 1mL232. M3563 , Monoclonal Mouse Anti-Human Epidermal Growth Factor Receptor, Clone H11,1mL233. M3568 , Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, 1mL234. M3569 , Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, 1mL235. M3571 , Monoclonal Mouse Anti-Human CD1a, Clone O10, 1mL236. M3575 , Monoclonal Mouse Anti-Thyroid Transcription Factor, Clone 8G7G3/1, 1mL237. M3612 , Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, 1mL238. M3614 , Monoclonal Mouse Anti-Human Thymidylate Synthase, Clone TS106, 1mL239. M3615 , Monoclonal Mouse Anti-Human Prostein, Clone 10E3, 0.2mL240. M3616 , Monoclonal Rabbit Anti-Human AMACR, Clone 13H4, 1mL241. M3617, Monoclonal Mouse Anti-Human COX-2, Clone CX-294, 1mL242. M3619 , Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40, 1mL243. M3620 , Monoclonal Mouse Anti-Human Prostate-Specific Membrane Antigen, Clone 3E6,1mL244. M3621 , Monoclonal Mouse Anti-Human MITF, Clone D5, 0.2mL245. M3623 , Monoclonal Mouse Anti-Human Tyrosinase, Clone T311, 0.2mL246. M3624 , Monoclonal Mouse Anti-Human Survivin, Clone 12C4, 0.2mL247. M3625 , Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, 0.2mL248. M3626, Monoclonal Mouse Anti-Human IMP3, Clone 69.1, 0.2mL249. M3627 , Monoclonal Mouse Anti-Human PTEN, Clone 6H2.1, 0.2mL250. M3631 , Monoclonal Mouse Anti-Human CD15 Clone Carb-3, 1mL251. M3632 , Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, 1mL252. M3636 , Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2, 1mL253. M3638 , Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone 23A3,



1mL254. M3639 , Monoclonal Mouse Anti-Human MutS Protein Homolog 2, Clone FE11, 1mL255. M3640 , Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, 1mL256. M3641 , Monoclonal Mouse Anti-Human CD5, Clone 4C7, 1mL257. M3642 , Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, 1mL258. M3646 , Monoclonal Rabbit Anti-Human MutS Protein Homolog 6, Clone EP49 , 1mL259. M3647 , Monoclonal Rabbit Anti-Human Postmeiotic Segregation Increased 2, Clone EP51,1mL260. M3649 , Monoclonal Mouse Anti-Human Octamer-binding Transcription Factor 3/4 (Oct3/4),Clone N1NK, 0.2mL261. M3651 , Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, CloneEP266, 1mL262. M3652 , Monoclonal Rabbit Anti-Human Cytokeratin 8/18, Clone EP17/EP30, 1mL263. M0613, Monoclonal Mouse Anti-Human Epithelial Membrane Antigen Clone E29, 1mL264. M0616, Monoclonal Mouse Anti-Human Von Willebrand Factor Clone F8/86, 1mL265. M0701, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen Clones 2B11 +PD7/26, 1mL266. M0725, Monoclonal Mouse Anti- Vimentin Clone V9, 1mL267. M0736, Monoclonal Mouse Anti-Human HLA-ABC Antigen Clone W6/32, 1mL268. M0737, Monoclonal Mouse Anti- Rabbit Immunoglobulins Clone MR12/53, 1mL269. M0742, Monoclonal Mouse Anti-Human CD45R0 Clone UCHL1, 1mL270. M0746, Monoclonal Mouse Anti-Human HLA-DR Antigen, Alpha-Chain Clone TAL.1B5, 1mL271. M0747, Monoclonal Mouse Anti-Human Myeloid/Histiocyte Antigen Clone MAC 387, 1mL272. M0751, Monoclonal Mouse Anti-Human CD30 Clone Ber-H2, 1mL273. M0752, Monoclonal Mouse Anti-Human Neutrophil Elastase Clone NP57, 1mL274. M0753, Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa Clone Y2/51, 1mL275. M0755, Monoclonal Mouse Anti-Human CD20cy Clone L26, 1mL276. M0758, Monoclonal Mouse Anti-Human Serotonin Clone 5HT-H209, 1mL277. M0759, Monoclonal Mouse Anti-Human Amyloid A Clone mc1, 1mL278. M0760, Monoclonal Mouse Anti-Human Desmin Clone D33, 1mL279. M0761, Monoclonal Mouse Anti-Human Glial Fibrillary Acidic Protein Clone 6F2, 1mL280. M0762, Monoclonal Mouse Anti-Human Neurofilament Protein Clone 2F11, 0.2mL281. M0775, Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen Clone CR3/43, 1mL282. M0781, Monoclonal Mouse Anti-Human Thyroglobulin Clone DAK-Tg6, 1mL283. M0784, Monoclonal Mouse Anti-Human CD21 Clone 1F8, 1mL284. M0785, Monoclonal Mouse Anti-Human Collagen IV Clone CIV 22, 1mL285. M0786, Monoclonal Mouse Anti-Human CD43 Clone DF-T1, 1mL286. M0792, Monoclonal Mouse Anti-Human Prostatic Acid Phosphatase Clone PASE/4LJ, 1mL287. M0804, Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4, 1mL288. M0814, Monoclonal Mouse Anti-Human CD68 Clone KP1, 1mL289. M0819, Monoclonal Mouse Anti-Human CD235a, Glycophorin A Clone JC159, 1mL290. M0820, Monoclonal Mouse Anti-Human Glycophorin C Clone Ret40f, 1mL291. M0821, Monoclonal Mouse Anti-Human Cytokeratin Clone MNF116, 1mL292. M0823, Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A, 1mL293. M0825, Monoclonal Mouse Anti-Human CD14 Clone TÜK4, 1mL294. M0846, Monoclonal Mouse Anti-Human CD35 Clone Ber-MAC-DRC, 1mL295. M0851, Monoclonal Mouse Anti-Human Smooth Muscle Actin Clone 1A4, 1mL296. M0869, Monoclonal Mouse Anti-Human Chromogranin A Clone DAK-A3, 1mL297. M0872, Monoclonal Mouse Anti-Human Beta-Amyloid Clone 6F/3D, 1mL298. M0873, Monoclonal Mouse Anti-Human Neuron-Specific Enolase Clone BBS/NC/VI-H14,1mL



299. M0874, Monoclonal Mouse Anti- Sarcomeric Actin Clone Alpha-Sr-1, 1mL300. M0876, Monoclonal Mouse Anti-Human CD68 Clone PG-M1, 1mL301. M0879, Monoclonal Mouse Anti- Proliferating Cell Nuclear Antigen Clone PC10, 1mL302. M0880, Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44, 1mL303. M0887, Monoclonal Mouse Anti-Human BCL2 Oncoprotein Clone 124, 1mL304. M0888, Monoclonal Mouse Anti-Human Cytokeratin 19 Clone RCK108, 1mL305. M0897, Monoclonal Mouse Anti- Epstein-Barr Virus, LMP Clones CS. 1-4, 1mL306. M7001, Monoclonal Mouse Anti-Human p53 Protein Clone DO-7, 1mL307. M7002, Monoclonal Mouse Anti-Human Cytokeratin 10 Clone DE-K10, 1mL308. M7010, Monoclonal Mouse Anti-Human Cytokeratin 18 Clone DC 10, 0.2mL309. M7018, Monoclonal Mouse Anti-Human Cytokeratin 7 Clone OV-TL 12/30, 1mL310. M7019, Monoclonal Mouse Anti-Human Cytokeratin 20 Clone Ks20.8, 1mL311. M7020, Monoclonal Mouse Anti- Vimentin Clone Vim 3B4, 1mL312. M7046, Monoclonal Mouse Anti- Cytokeratin 17 Clone E3, 1mL313. M7050, Monoclonal Mouse Anti-Human CD79a Clone JCB117, 1mL314. M7052, Monoclonal Mouse Anti-Human Mast Cell Tryptase Clone AA1, 0.2mL315. M7064, Monoclonal Mouse Anti- Enterovirus Clone 5-D8/1, 1mL316. M7072, Monoclonal Mouse Anti-Human Carcinoembryonic Antigen Clone II-7, 1mL317. M7077, Monoclonal Mouse Anti-Human Plasma Cell Clone VS38c, 1mL318. M7082, Monoclonal Mouse Anti-Human CD44, Phagocytic Glycoprotein-1 Clone DF1485,1mL319. M7103, Monoclonal Mouse Anti-Human CD8 Clone C8/144B, 1mL320. M7157, Monoclonal Mouse Anti-Human Follicular Dendritic Cell Clone CNA.42, 1mL321. M7158, Monoclonal Mouse Anti-Human Hepatocyte Clone OCH1E5, 1mL322. M7165, Monoclonal Mouse Anti-Human CD34 Class II Clone QBEnd 10, 1mL323. M7191, Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase Clone 8A9, 1mL324. M7195, Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK1, 1mL325. M7196, Monoclonal Mouse Anti-Human Melan-A Clone A103, 1mL326. M7202, Monoclonal Mouse Anti-Human p21WAF1/Cip1, Clone SX118, 0.2mL327. M7203, Monoclonal Mouse Anti-Human p27Kip1, Clone SX53G8, 1mL328. M7211, Monoclonal Mouse Anti-Human BCL6 Protein Clone PG-B6p, 1mL329. M7228, Monoclonal Mouse Anti-Human CD138 Clone MI15, 1mL330. M7235, Monoclonal Mouse Anti-Human Granzyme B Clone GrB-7, 1mL331. M7237, Monoclonal Mouse Anti-Human Cytokeratin 5/6 Clone D5/16 B4, 1mL332. M7239, Monoclonal Mouse Anti-Human Epidermal Growth Factor Receptor Clone E30, 1mL333. M7240, Monoclonal Mouse Anti-Human Ki-67 Antigen Clone MIB-1, 1mL334. M7245, Monoclonal Mouse Anti-Human Calretinin Clone DAK-Calret 1, 1mL335. M7254, Monoclonal Mouse Anti-Human CD3 Clone F7.2.38, 1mL336. M7255, Monoclonal Mouse Anti-Human CD7 Clone CBC.37, 1mL337. M7257, Monoclonal Mouse Anti-Human Thyroid Peroxidase Clone MoAb47, 0.2mL338. M7259, Monoclonal Mouse Anti-Human MUM1 Protein Clone MUM1p, 1mL339. M7260, Monoclonal Mouse Anti-Human BCL10 Protein Clone 151, 0.2mL340. M7271, Monoclonal Mouse Anti-Human CD57 Clone TB01, 0.2mL341. M7279, Monoclonal Mouse Anti-Human LAT Protein Clone LAT-1, 0.2mL342. M7296, Monoclonal Mouse Anti-Human CD19 Clone LE-CD19, 0.2mL343. M7304, Monoclonal Mouse Anti-Human CD56 Clone 123C3, 1mL344. M7307, Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein Clone DAK-Pax5,1mL345. M7310, Monoclonal Mouse Anti-Human CD4 Clone 4B12, 1mL346. M7312, Monoclonal Mouse Anti-Human CD23 Clone DAK-CD23, 1mL347. M7313, Monoclonal Mouse Anti-Human MUC2 Clone CCP58, 1mL



348. M7315, Monoclonal Mouse Anti-Human Synaptophysin Clone DAK-SYNAP, 1mL349. M7317, Monoclonal Mouse Anti-Human p63 Protein Clone DAK-p63, 1mL350. PR701, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/PerCP Clone2D1, 1mL351. PR702, Monoclonal Mouse Anti-Human CD3/PerCP Clone UCHT1, 1mL352. PR703, Monoclonal Mouse Anti-Human CD19/PerCP-Cy5.5, Clone HD37, 0.5mL353. PR704, Monoclonal Mouse Anti-Human Myeloperoxidase/PerCP-Cy5.5, Clone MPO-7,0.5mL354. PR706, Monoclonal Mouse Anti-Human CD34/PerCP-Cy5.5, Clone BIRMA-K3, 1mL355. R0715, Monoclonal Mouse Anti-Human CD13/RPE Clone WM-47, 1mL356. R0745, Monoclonal Mouse Anti-Human CD33/RPE Clone WM-54, 1mL357. R0805, Monoclonal Mouse Anti-Human CD4/RPE Clone MT310, 1mL358. R0806, Monoclonal Mouse Anti-Human CD8/RPE Clone DK25, 1mL359. R0807, Monoclonal Mouse Anti-Human CD2/RPE Clone MT910, 1mL360. R0808, Monoclonal Mouse Anti-Human CD19/RPE Clone HD37, 1mL361. R0810, Monoclonal Mouse Anti-Human CD3/RPE Clone UCHT1, 1mL362. R0811, Monoclonal Mouse Anti-Human CD25, Interleukin-2 Receptor/RPE Clone ACT-1,1mL363. R0842, Monoclonal Mouse Anti-Human CD5/RPE Clone DK23, 1mL364. R0843, Monoclonal Mouse Anti-Human CD45R0/RPE Clone UCHL1, 1mL365. R0848, Monoclonal Mouse Anti-Human CD10/RPE Clone SS2/36, 1mL366. R0864, Monoclonal Mouse Anti-Human CD14/RPE Clone TÜK4, 1mL367. R7000, Monoclonal Mouse Anti-Human HLA-ABC Antigen/RPE Clone W6/32, 1mL368. R7012, Monoclonal Mouse Anti-Human CD16, Fc Gamma Receptor III/RPE Clone DJ130c,1mL369. R7013, Monoclonal Mouse Anti-Human CD20/RPE Clone B-Ly1, 1mL370. R7014, Monoclonal Mouse Anti-Human CD42b, Platelet Glycoprotein Ib/RPE Clone AN51,1mL371. R7058, Monoclonal Mouse Anti-Human CD41, Platelet Glycoprotein IIb/RPE Clone 5B12,1mL372. R7061, Monoclonal Mouse Anti-Human CD22/RPE Clone 4KB128, 1mL373. R7078, Monoclonal Mouse Anti-Human CD235a, Glycophorin A/ RPE Clone JC159, 1mL374. R7086, Monoclonal Mouse Anti-Human CD45RA/RPE Clone 4KB5, 1mL375. R7087, Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE CloneT29/33, 1mL376. R7108, Monoclonal Mouse Anti-Human CD23/RPE Clone MHM6, 1mL377. R7125, Monoclonal Mouse Anti-Human CD34 Class III/RPE Clone BIRMA-K3, 1mL378. R7127, Monoclonal Mouse Anti-Human CD56/RPE Clone MOC-1, 1mL379. R7144, Monoclonal Mouse Anti-Human CD38/RPE Clone AT13/5, 1mL380. R7145, Monoclonal Mouse Anti-Human CD117, c-kit/RPE Clone 104D2, 1mL381. R7159, Monoclonal Mouse Anti-Human CD79acy/RPE Clone HM57, 1mL382. R7188, Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocyte Antigen/RPE CloneBer-ACT8, 1mL383. R7189, Monoclonal Mouse Anti-Human CD1a/RPE Clone NA1/34, 1mL384. R7209, Monoclonal Mouse Anti-Human Myeloperoxidase/RPE Clone MPO-7, 1mL385. R7219, Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/RPE Clone 10.1, 1mL386. R7229, Monoclonal Mouse Anti-Human CD138/RPE Clone MI15, 1mL387. R7251, Monoclonal Mouse Anti-Human CD56/RPE Clone C5.9, 1mL388. R7267, Monoclonal Mouse Anti-Human HLA-DR Antigen/RPE Clone AB3, 1mL389. R7272, Monoclonal Mouse Anti-Human CD79ß/RPE Clone SN8, 1mL390. R7277, Monoclonal Mouse Anti-Human CD7/RPE Clone CBC.37, 1mL



391. FR044, MultiMix Dual-Colour Reagent Anti-Human Lambda Light Chains/FITC Anti-HumanCD19/RPE, 0.5mL392. FR048, MultiMix Dual-Colour Reagent Anti-Human Kappa Light Chains/FITC Anti-HumanCD19/RPE, 0.5mL393. FR481, MultiMix Dual-Colour Reagent Anti-Human Kappa Light Chains/FITC Anti-HumanLambda Light Chains/RPE, 0.2mL394. FR700, MultiMix Dual-Colour Reagent Anti-Human CD45/FITC Anti-Human CD14/RPE,0.5mL395. FR729, MultiMix Dual-Colour Reagent Anti-Human CD5/FITC Anti-Human CD20/RPE,0.5mL396. FR866, MultiMix Dual-Colour Reagent Anti-Human CD3/FITC Anti-Human CD19/RPE,0.5mL397. FR867, MultiMix Dual-Colour Reagent Anti-Human HLA-DP, DQ, DR Antigen/FITC Anti-Human CD3/RPE, 0.5mL398. FR868, MultiMix Dual-Colour Reagent Anti-Human CD4/FITC Anti-Human CD8/RPE, 0.5mL399. FR875, MultiMix Dual-Colour Reagent Anti-Human CD3/FITC Anti-Human CD4/RPE, 0.5mL400. FR881, MultiMix Dual-Colour Reagent Anti-Human CD3/FITC Anti-Human CD8/RPE, 0.5mL401. FR882, MultiMix Dual-Colour Reagent Anti-Human CD5/FITC Anti-Human CD19/RPE,0.5mL402. FR883, MultiMix Dual-Colour Reagent Anti-Human CD10/FITC Anti-Human CD19/RPE,0.5mL403. FR894, MultiMix Dual-Colour Reagent Anti-Human CD2/FITC Anti-Human CD19/RPE,0.5mL404. TC051, MultiMix Triple-Colour Reagent Anti-Human Kappa Light Chains/FITC Anti-HumanLambda Light Chains/RPE Anti-Human CD19/RPE-Cy5, 0.5mL405. TC641, MultiMix Triple-Colour Reagent Anti-Human CD8/FITC Anti-Human CD4/RPE Anti-Human CD3/RPE-Cy5, 0.5mL406. TC660, MultiMix Triple-Colour Reagent Anti-Human CD8/FITC Anti-Human CD4/RPE Anti-Human CD3/APC, 1mL407. TC661, MultiMix Triple-Colour Reagent Anti-Human CD16/FITC Anti-Human CD56/RPEAnti-Human CD3/APC, 1mL408. TC663, MultiMix Triple-Colour Reagent Anti-Human CD20/FITC Anti-Human CD5/RPE Anti-Human CD19/APC, 1mL409. TC664, MultiMix Triple-Colour Reagent Anti-Human CD5/FITC Anti-Human CD10/RPE Anti-Human CD19/APC, 1mL410. TC665, MultiMix Triple-Colour Reagent Anti-Human CD103/FITC Anti-Human CD11c/RPEAnti-Human CD19/APC, 1mL411. TC666, MultiMix Triple-Colour Reagent Anti-Human CD2/FITC Anti-Human CD34/RPE Anti-Human CD5/APC, 1mL412. TC667, MultiMix Triple-Colour Reagent Anti-Human MPO/FITC Anti-Human CD79acy/RPEAnti-Human CD3/APC, 1mL413. TC668, MultiMix Triple-Colour Reagent Anti-Human TdT/FITC Anti-Human CD22/RPE Anti-Human CD3/APC, 1mL414. TC669, MultiMix Triple-Colour Reagent Anti-Human CD19/FITC Anti-Human Lambda LightChains/RPE Anti-Human Kappa Light Chains/APC, 1mL415. TC670, MultiMix Triple-Colour Reagent Anti-Human Plasma Cell/FITC Anti-Human LambdaLight Chains/RPE Anti-Human Kappa Light Chains/APC, 1mL416. TC671, MultiMix Triple-Colour Reagent Anti-Human CD38/FITC Anti-Human CD56/RPEAnti-Human CD45/APC, 1mL417. TC674, MultiMix Triple-Colour Reagent Anti-Human CD38/FITC Anti-Human CD56/RPEAnti-Human CD19/APC, 1mL



418. TC675, MultiMix Triple-Colour Reagent Anti-Human CD71/FITC Anti-Human CD235a/RPEAnti-Human CD45/APC, 1mL419. TC677, MultiMix Triple-Colour Reagent Anti-Human CD2/FITC Anti-Human CD7/RPE Anti-Human CD3/APC, 1mL420. TC683, MultiMix Triple-Colour Reagent Anti-Human B Cell (FMC7)/FITC Anti-HumanCD23/RPE Anti-Human CD19/APC, 1mL421. TC685, MultiMix Triple-Colour Reagent Anti-Human CD13/FITC Anti-Human HLA-DRAntigen/RPE Anti-Human CD117/APC, 1mL422. TC686, MultiMix Triple-Colour Reagent Anti-Human CD33/FITC Anti-Human CD34/RPEAnti-Human CD117/APC, 1mL423. TC687, MultiMix Triple-Colour Reagent Anti-Human CD41/FITC Anti-Human CD34/RPEAnti-Human CD61/APC, 1mL424. TC689, MultiMix Triple-Colour Reagent Anti-Human CD19/FITC Anti-Human CD34/RPEAnti-Human CD22/APC, 1mL425. TC690, MultiMix Triple-Colour Reagent Anti-Human CD3/FITC Anti-Human CD19/RPE Anti-Human CD45/APC, 1mL426. X0932, MultiMix Dual-Colour Control Reagent Mouse IgG1/FITC Mouse IgG1/RPE, 0.5mL427. X0935, MultiMix Dual-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPE,0.5mL428. X0949, MultiMix Dual-Colour Control Reagent Mouse IgG1/FITC Mouse IgG2a/RPE, 0.5mL429. X0952, MultiMix Dual-Colour Control Reagent Rabbit F(ab')2/FITC Mouse IgG1/RPE, 0.5mL430. X0956, MultiMix Triple-Colour Control Reagent Mouse IgG1/FITC Mouse IgG1/RPE MouseIgG1/RPE-Cy5, 0.5mL431. X0957, MultiMix Triple-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPEMouse IgG1/RPE-Cy5, 0.5mL432. X0978, MultiMix Triple-Colour Control Reagent Mouse IgG1/FITC Mouse IgG1/RPE MouseIgG1/APC, 1mL433. X0979, MultiMix Triple-Colour Control Reagent Mouse IgG1/FITC Rabbit F(ab')2/RPE RabbitF(ab')2/APC, 1mL

Presentaciones:

por unidad (VER LISTADO DE PRODUCTO).

Uso previsto:Para el análisis multiparamétrico utilizando diferentes técnicas para inmunodiagnóstico: IHC(inmunohistoquímica), ICQ (inmunocitoquímica), CF (Citometría de Flujo), IB (Inmunoblotting). IP(Inmunoprecipitación), TB (Turbidimetría), NF (Nefelometría), ELISA (Enzimainmunoensayo), IF(imunofijación), FISH (hibridización in situ fluorescente), CISH (hibridización in situ cromogénica).

Período de vida útil:

• Vida útil de 36 meses: 18 y 19 / 21 al 34 / 36 al 49 / 51 al 59 / 61 / 263 al 298 / 300 y 301 / 303al 319 / 321 al 334 / 336 al 339 / 341 / 343 / 391 al 403 / 426 al 429.• Vida útil de 24 meses: 1 al 8 / 10 al 17 / 20 / 35 / 50 / 60 / 79 y 80 / 82 y 83 / 85 / 87 al 95 / 97 y98 / 101 / 103 y 104 / 106 y 107 / 109 / 111 / 114 al 169 / 171 al 225 / 227 al 242 / 244 al 245 /247 / 253 / 256 / 299 / 302 / 320 / 335 / 340 / 344 al 390 / 404 al 425 / 430 al 433.• Vida útil de 18 meses: 78 / 84 / 108 / 170.• Vida útil de 14 meses: 226 / 243.• Vida útil de 12 meses: 9 / 62 al 77 / 81 / 86 / 96 / 99 y 100 / 102 / 105 / 110 / 112 y 113 / 246 /249 al 252 / 254 / 255 / 257 al 259 / 261 y 262 / 342.• Vida útil de 10 meses: 260.



• Vida útil de 6 meses: 248.

Todos los productos deben almacenarse de 2 a 8°C.

Nombre y domicilio del fabricante:

Dako Denmark ApS, Produktionsvej 42, 2600 Glostrup, Dinamarca: 1 al 61 / 69 / 72 al 179 / 263al 433.

Dako North America Inc, 6392 Via real, Carpinteria, CA USA 93013, Estados Unidos de América:62 al 68 / 70 y 71 / 180 al 262.

Categoría:

Venta exclusiva a laboratorios de análisis clínicos. USO PROFESIONAL EXCLUSIVO

LUGAR Y FECHA: Argentina, 08 junio 2020

Responsable LegalFirma y Sello

Responsable TécnicoFirma y Sello

Ministerio de Salud

Secretaria de Calidad en Salud



A.N.M.A.T.

La presente DECLARACIÓN DE CONFORMIDAD ha sido emitida de acuerdo con las previsionesde la Disposición ANMAT Nº 2275/06, quedando autorizada la comercialización del/losproducto/s identificados en la misma.Inscripta en el Registro Nacional de Productores y Productos de Tecnología Médica (R.P.P.T.M.)bajo el número PM 1252-181Ciudad de Buenos Aires a los días 08 junio 2020

Dirección de Evaluación de Registro

Firma y Sello

Instituto Nacional de Productos MédicosFirma y Sello

La validez del presente documento deberá verificarse mediante el código QR.

Tramitada por Expediente N°: 1-0047-3110-003782-20-5



DECLARACIÓN DE CONFORMIDAD · 31. F0817, Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/ FITC...

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Transcript of DECLARACIÓN DE CONFORMIDAD · 31. F0817, Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/ FITC...