ФС № 2005/1543

Регистрационное удостоверение на медицинское изделие ФС № 2005/1543
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ
ЗДРАВООХРАНЕНИЯ
(РОСЗДРАВНАДЗОР)
РЕГИСТРАЦИОННОЕ УДОСТОВЕРЕНИЕ
НА МЕДИЦИНСКОЕ ИЗДЕЛИЕ
от 19.10.2005 № ФС № 2005/1543
На медицинское изделие
Реагенты и расходные материалы для определения группы крови и скрининга антител (см. Приложение на 7 листах)1. 001014 ABO/Rh human 4x12 2. 001013 BO/Rh human 24x12 3. 001016 ABO/Rh human 60x12 4. 001015 ABO/Rh human 112x12 5. 001114 ABD-Confirmation human 4x12 6. 001117 ABD-Confirmation human 24x12 7. 001116 ABD-Confirmation human 60x12 8. 001115 ABD-Confirmation human 112x12 9. 001017 ABO/Rh newborns human 4x12 10. 001020 ABO/Rh newborns human 24x12 11. 001018 ABO/Rh newborns human 60x12 12. 001019 ABO/Rh newborns human 112x12 13. 001044 DiaClon ABO/Rh for patients 4x12 14. 001043 DiaClon ABO/Rh for patients 24x12 15. 001046 DiaClon ABO/Rh for patients 60x12 16. 001045 DiaClon ABO/Rh for patients 112x12 17. 001254 DiaClon ABD-confirmation for patients 4x12 18. 001257 DiaClon ABD-confirmation for patients 24x12 19. 001256 DiaClon ABD-confirmation for patients 60x12 20. 001255 DiaClon ABD-confirmation for patients 112x12 21. 001047 DiaClon ABO/Rh for newborns 4x12 22. 001048 DiaClon ABO/Rh for newborns 24x12 23. 001049 DiaClon ABO/Rh for newborns 60x12 24. 001050 DiaClon ABO/Rh for newborns 112x12 25. 001037 DiaClon ABO/Rh for donors 4x12 26. 001033 DiaClon ABO/Rh for donors 24x12 27. 001039 DiaClon ABO/Rh for donors 60x12 28. 001038 DiaClon ABO/Rh for donors 112x12 29. 001134 DiaClon ABD-confirmation for donors 4x12 30. 001133 DiaClon ABD-confirmation for donors 24x12 31. 001136 DiaClon ABD-confirmation for donors 60x12 32. 001135 DiaClon ABD-confirmation for donors 112x12 33. 001334 ABO/D human 4x12 34. 001337 ABO/D human 24x12 35. 001336 ABO/D human 60x12 36. 001335 ABO/D human 112x12 37. 001324 DiaClon ABO/D 4x12 38. 001323 DiaClon ABO/D 24x12 39. 001326 DiaClon ABO/D 60x12 40. 001325 DiaClon ABO/D 112x12 41. 001344 DiaClon ABO/D+DAT 4x12 42. 001347 DiaClon ABO/D + DAT 24x12 43. 001346 DiaClon ABO/D + DAT 60x12 44. 001345 DiaClon ABO/D + DAT 112x12 45. 001127 ABO/D + reverse grouping human 4x12 46. 001131 ABO/D + reverse grouping human 24x12 47. 001128 ABO/D + reverse grouping human 60x12 48. 001129 ABO/D + reverse grouping human 112x12 49. 001234 DiaClon ABO/D + reverse grouping 4x12 50. 001237 DiaClon ABO/D + reverse grouping 24x12 51. 001236 DiaClon ABO/D + reverse grouping 60x12 52. 001386 DiaClon ABO/D + reverse grouping 112x12 53. 001235 DiaClon ABO/D + reverse grouping 112x12 54. 002114 Rh-subgroups+K human 4X12 55. 002117 Rh-subgroups+K human 24x12 56. 002116 Rh-subgroups+K human 60x12 57. 002115 Rh-subgroups+K human 112x12 58. 002124 DiaClon Rh-subgroups +K 4x12 59. 002127 DiaClon Rh-subgroups +K 24x12 60. 002126 DiaClon Rh-subgroups +K 60x12 61. 002125 DiaClon Rh-subgroups +K 112x12 62. 002014 Rh-subgr+Cw+K human 4x12 63. 002017 Rh-subgr+Cw+K human 24x12 64. 002016 Rh-subgr+Cw+K human 60x12 65. 002015 Rh-subgr+Cw+K human 112x12 66. 002024 Rh D phenotype human 4x12 67. 002027 Rh D phenotype human 24x12 68. 002026 Rh D phenotype human 60x12 69. 002025 Rh D phenotype human 112x12 70. 001811 Anti-A1 human 1х12 71. 001911 Anti-H monoclonal 1х12 72. 001451 Partial D typing 1х12 73. 104755 DiaClon Anti-K 1x5 ml 74. 104758 DiaClon Anti-K 100x5 ml 75. 104760 DiaClon Anti-K 1x10 ml 76. 104761 DiaClon Anti-K 10x10 ml 77. 104769 DiaClon Anti-K 100x10 ml 78. 100710 DiaClon Anti-А 1x10 ml 79. 100711 DiaClon Anti-А 10x10 ml 80. 100719 DiaClon Anti-А 100x10 ml 81. 100810 DiaClon Anti-B 1x10 ml 82. 100811 DiaClon Anti-B 10x10 ml 83. 100819 DiaClon Anti-B 100x10 ml 84. 101070 DiaClon Anti-D 1x10 ml 85. 101071 DiaClon Anti-D 10x10 ml 86. 101079 DiaClon Anti-D 100x10 ml 87. 007531 Anti-D 1x5 ml 88. 004024 Coombs Anti-IgG 4x12 89. 004027 Coombs Anti-IgG 24x12 90. 004026 Coombs Anti-IgG 60x12 91. 004025 Coombs Anti-IgG 112x12 92. 008510 Antigen profile I 1x12 93. 008516 Antigen profile I 60x12 94. 008610 Antigen profile II 1x12 95. 008616 Antigen profile II 60x12 96. 008701 Antigen profile III card 1x12 97. 008711 Testsera 6x1,4 ml 98. 001211 Anti-D 1x12 99. 001213 Anti-D 24x12 100. 001216 Anti-D 60x12 101. 001251 DiaClon anti-DVI neg 1x12 102. 001252 DiaClon anti-DVI neg 24x12 103. 001253 DiaClon anti-DVI neg 60x12 104. 001311 Anti-Cw 1x12 105. 002111 Anti-K human 1x12 106. 002118 Anti-K human 24x12 107. 002112 Anti-K human 60x12 108. 002121 DiaClon Anti-K 1x12 109. 002128 DiaClon Anti-K 24x12 110. 002112 DiaClon Anti-K 60x12 111. 007251 Anti-k human 1x12 112. 007011 Anti-M monoclonal 1x12 113. 007111 Anti-N monoclonal 1x12 114. 007211 Anti-P1 goat 1x12 115. 007221 Anti-Lea monoclonal 1x12 116. 004025 Coombs Anti-IgG 1x12 117. 004851 DC Screening I 1x12 118. 007231 Anti-Leb monoclonal 1x12 119. 007321 Anti-Jka monoclonal 1x12 120. 007331 Anti-Jkb monoclonal 1x12 121. 007301 Anti-Kpa human 1x12 122. 007311 Anti-Kpb human 1x12 123. 007351 Anti-Lua human 1x12 124. 007361 Anti-Lub human 1x12 125. 007130 Test of Antigen S card 1x12 126. 007131 Test of Antigen S sera human 1x3,6 ml 127. 007140 Test of Antigen s card 1x12 128. 007141 Test of Antigen S sera human 1x3,6 ml 129. 007270 Test of antigen Fya card 1x12 130. 007271 Test of antigen Fya sera human 1x3,6 ml 131. 007280 Test of antigen Fyb card 1x12 132. 007281 Test of antigen Fyb sera human 1x3,6 ml 133. 007370 ID-card Anti-I 1x0,5 ml 134. 007380 ID-card Anti-i 1x0,5 ml 135. 007440 ID-card Anti-Cob 1x0,5 ml 136. 007400 ID-card Anti-Jsa 1x0,5 ml 137. 007390 ID-Card Anti Jsb 1x0,50ml 138. 007410 ID-Card Antri-Wra 1x0,50ml 139. 007420 ID-Card Anti-Dia 1x0,5 ml 140. 007430 ID-Card Anti-Vel 1x0,5 ml 141. 007450 ID-Card Anti Vw 1x0,5 ml 142. 007460 ID-Card Anti-Xga 1x0,5 ml 143. 007470 ID-Card Anti-U 1x0,5 ml 144. 007490 ID-Card Anti-Tja 1x10,5 ml 145. 003014 Reverse grouping + antibody screening 4x12 146. 003017 Reverse grouping + antibody screening 24x12 147. 003016 Reverse grouping + antibody screening 60x12 148. 003015 Reverse grouping + antibody screening 112x12 149. 005014 NaCl + enzyme test 4x12 150. 005017 NaCl + enzyme test 24x12 151. 005016 NaCl + enzyme test 60x12 152. 005015 NaCl + enzyme test 112x12 153. 004014 LISS/Coombs 4x12 154. 004017 LISS/Coombs 24x12 155. 004016 LISS/Coombs 60x12 156. 004015 LISS/Coombs 112x12 157. 004024 Coombs Anti-IgG 4x12 158. 004027 Coombs Anti-IgG 24x12 159. 004026 Coombs Anti-IgG 60x12 160. 004851 DC Screening I 4x12 161. 004857 DC Screening I 24x12 162. 004856 DC Screening I 60x12 163. 004855 DC Screening I 112x12 164. 004831 DC Screening II 4x12 165. 004837 DC Screening II 24x12 166. 004836 DC Screening II 60x12 167. 004835 DC Screening II 112x12 168. 004033 DAT IgG Dilution 1x12 169. 004043 DAT IgG1-IgG3 1x12 170. 004704 DiaScreening 4x12 171. 004707 DiaScreening 24x12 172. 004706 DiaScreening 60x12 173. 004705 DiaScreening 112x12 174. 004514 LISS/Coombs /enzyme test 4x12 175. 004517 LISS/Coombs /enzyme test 24x12 176. 004516 LISS/Coombs /enzyme test 60x12 177. 004515 LISS/Coombs /enzyme test 112x12 178. 002437 DiaClon Type and screen 4x12 179. 002431 DiaClon Type and screen 24x12 180. 002439 DiaClon Type and screen 60x12 181. 002438 DiaClon Type and screen 112x12 182. 004604 Complete Crossmatch 4x12 183. 004607 Complete Crossmatch 24x12 184. 004606 Complete Crossmatch 60x12 185. 004605 Complete Crossmatch 112x12 186. 004614 DiaClon Complete crossmatch 4x12 187. 004617 DiaClon Complete crossmatch 24x12 188. 004616 DiaClon Complete crossmatch 60x12 189. 004615 DiaClon Complete crossmatch 112x12 190. 009160 ID-Diluent 1 2x100 ml 191. 009180 ID-Diluent 1 1x500 ml 192. 009260 ID-Diluent 2 2x100 ml 193. 009280 ID-Diluent 2 1x500 ml 194. 005650 ID-Cell Stab 1x500 ml 195. 003619 ID-DiaCell ABO 4x10 ml 196. 003617 ID-DiaCell ABO 3x10 ml 197. 003615 ID-DiaCell ABO 3x10 ml 198. 003624 ID-DiaCell ABO 2x10 ml 199. 003620 D-DiaCell ABO A1 1x10 ml 200. 003621 ID-DiaCell ABO A2 1x10 ml 201. 003622 ID-DiaCell ABO B 1x10 ml 202. 003623 ID-DiaCell ABO O 1x10 ml 203. 003618 ID-DiaCell ABO/I-II-III 6x10 ml 204. 003610 ID-DiaCell ABO/I-II 6x10 ml 205. 004316 ID-DiaScreen 6x10 ml 206. 004311 ID-DiaScreen 6x10 ml 207. 005311 ID-DiaScreen 6x10 ml 208. 004310 ID-DiaCell I-II-III 3x10 ml 209. 003630 ID-DiaCell Pool 1x10 ml 210. 003631 ID-DiaCell Pool 3x10 ml 211. 007531 Anti-D 1x 5 ml 212. 009622 ID-Tips 1000kpl 213. 009612 ID-dispenser II - 214. 009611 Holder for dispenser - 215. 0084900 Suspension tubes 1x1000 216. 009821 Wash sol A 1x10 ml 217. 009822 Wash sol B 1x10 ml 218. 009818 Wash sol A conc 10x100 ml 219. 009819 Wash sol B conc 10x100 ml
Настоящее регистрационное удостоверение выдано
Производитель
DiaMed AG
Место производства медицинского изделия
Швейцария
Номер регистрационного досье № ФС № 2005/1543
Вид медицинского изделия: —
Код Общероссийского классификатора продукции для
медицинского изделия: ---
Приказом Росздравнадзора от 19.10.2005 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
По надзору в сфере здравоохранения
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