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: ---
медицинского изделия: ---
Приказом Росздравнадзора от 19.10.2005 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
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