Reagents for in vitro diagnostics and consumables for analyzers of the series: Synchron and Access (see Appendix on sheet 1)Reagents for biochemical analyzers of the Synchron series: 1. Cholinesterase Reagent Kit (CHE). 2. Homocysteine Reagent Kit (HCY UDR Kit). Reagents for immunochemical analyzers of the Access series: 3. Antibodies to thyroid peroxidase (reagent for determination) Access TPO ANTIBODY. 4. Antibodies to thyroid peroxidase (calibrator) Access TPO ANTIBODY CALIBRATORS. 5. Antibodies to thyroglobulin II (reagent for determination) Access THYROGLOBULIN ANTIBODY II. 6. Antibodies to thyroglobulin II (calibrator) Access THYROGLOBULIN ANTIBODY II CALIBRATORS. 7. Interleukin-6 (reagent for determination) Access IL-6. 8. Interleukin-6 (calibrator) Access IL-6 CALIBRATORS. 9. Interleukin-6 (control) Access IL-6 QC. 10. Intact parathyroid hormone (reagent for determination) Access INTACT PTH (iPTH). 11. Intact parathyroid hormone (calibrator) Access INTACT PTH (iPTH) CALIBRATORS. 12. Wash buffer 2 for Access Access WASH BUFFER II. 13. Wash buffer 2 for UniCel DxI UniCel DxI Access Immunoassay System Wash Buffer II. Analyzer accessories: 14. Sample cups 0.5 ml Sample cup 0.5 ml. 15. Sample cup 2.0 ml.
Russia·Unknown·Beckman Coulter Inc.·Registered December 28, 2006·N/A- Device Name (English)
- Reagents for in vitro diagnostics and consumables for analyzers of the series: Synchron and Access (see Appendix on sheet 1)Reagents for biochemical analyzers of the Synchron series: 1. Cholinesterase Reagent Kit (CHE). 2. Homocysteine Reagent Kit (HCY UDR Kit). Reagents for immunochemical analyzers of the Access series: 3. Antibodies to thyroid peroxidase (reagent for determination) Access TPO ANTIBODY. 4. Antibodies to thyroid peroxidase (calibrator) Access TPO ANTIBODY CALIBRATORS. 5. Antibodies to thyroglobulin II (reagent for determination) Access THYROGLOBULIN ANTIBODY II. 6. Antibodies to thyroglobulin II (calibrator) Access THYROGLOBULIN ANTIBODY II CALIBRATORS. 7. Interleukin-6 (reagent for determination) Access IL-6. 8. Interleukin-6 (calibrator) Access IL-6 CALIBRATORS. 9. Interleukin-6 (control) Access IL-6 QC. 10. Intact parathyroid hormone (reagent for determination) Access INTACT PTH (iPTH). 11. Intact parathyroid hormone (calibrator) Access INTACT PTH (iPTH) CALIBRATORS. 12. Wash buffer 2 for Access Access WASH BUFFER II. 13. Wash buffer 2 for UniCel DxI UniCel DxI Access Immunoassay System Wash Buffer II. Analyzer accessories: 14. Sample cups 0.5 ml Sample cup 0.5 ml. 15. Sample cup 2.0 ml.
- Device Name (Russian)
- Реагенты для in vitro диагностики и расходные материалы для анализаторов серий: Synchron и Access (см. Приложение на 1 листе)Реагенты для биохимических анализаторов серии Synchron: 1. Холинэстераза (реагент для определения) Cholinesterase Reagent Kit (CHE). 2. Гомоцистеин (реагент для определения) Homocysteine Reagent Kit (HCY UDR Kit). Реагенты для для иммунохимических анализаторов серии Access: 3. Антитела к тиреопероксидазе (реагент для определения) Access TPO ANTIBODY. 4. Антитела к тиреопероксидазе (калибратор) Access TPO ANTIBODY CALIBRATORS. 5. Антитела к тиреоглобулину II (реагент для определения) Access THYROGLOBULIN ANTIBODY II. 6. Антитела к тиреоглобулину II (калибратор) Access THYROGLOBULIN ANTIBODY II CALIBRATORS. 7. Интерлейкин-6 (реагент для определения) Access IL-6. 8. Интерлейкин-6 (калибратор) Access IL-6 CALIBRATORS. 9. Интерлейкин-6 (контроль) Access IL-6 QC. 10. Интактный паратиреоидный гормон (реагент для определения) Access INTACT PTH (iPTH). 11. Интактный паратиреоидный гормон (калибратор) Access INTACT PTH (iPTH) CALIBRATORS. 12. Промывающий буфер 2 для системы Access Access WASH BUFFER II. 13. Промывающий буфер 2 для системы UniCel DxI UniCel DxI Access Immunoassay System Wash Buffer II. Принадлежности для анализаторов: 14. Чашечки для образцов 0.5мл Sample cup 0.5 ml. 15. Чашечки для образцов 2.0мл Sample cup 2.0 ml.
- Device Type (English)
- N/A
- Device Type (Russian)
- Unknown
- Risk Class
- N/A
- Registry Key
- o77805
- Registration Number
- ФС № 2006/2643
- Registration Date
- December 28, 2006
- Validity Period
- December 28, 2011
- Manufacturer Name (English)
- Beckman Coulter Inc.
- Manufacturer Name (Russian)
- Beckman Coulter Inc.
- Country (English)
- USA
- Country (Russian)
- USA
- Legal Address (English)
- USA, Ireland, France
- Legal Address (Russian)
- США Ирландия Франция
Access comprehensive regulatory information for Reagents for in vitro diagnostics and consumables for analyzers of the series: Synchron and Access (see Appendix on sheet 1)Reagents for biochemical analyzers of the Synchron series: 1. Cholinesterase Reagent Kit (CHE). 2. Homocysteine Reagent Kit (HCY UDR Kit). Reagents for immunochemical analyzers of the Access series: 3. Antibodies to thyroid peroxidase (reagent for determination) Access TPO ANTIBODY. 4. Antibodies to thyroid peroxidase (calibrator) Access TPO ANTIBODY CALIBRATORS. 5. Antibodies to thyroglobulin II (reagent for determination) Access THYROGLOBULIN ANTIBODY II. 6. Antibodies to thyroglobulin II (calibrator) Access THYROGLOBULIN ANTIBODY II CALIBRATORS. 7. Interleukin-6 (reagent for determination) Access IL-6. 8. Interleukin-6 (calibrator) Access IL-6 CALIBRATORS. 9. Interleukin-6 (control) Access IL-6 QC. 10. Intact parathyroid hormone (reagent for determination) Access INTACT PTH (iPTH). 11. Intact parathyroid hormone (calibrator) Access INTACT PTH (iPTH) CALIBRATORS. 12. Wash buffer 2 for Access Access WASH BUFFER II. 13. Wash buffer 2 for UniCel DxI UniCel DxI Access Immunoassay System Wash Buffer II. Analyzer accessories: 14. Sample cups 0.5 ml Sample cup 0.5 ml. 15. Sample cup 2.0 ml. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФС № 2006/2643 and manufactured by Beckman Coulter Inc.. The device was registered on December 28, 2006.
This page provides complete registration details including device type, manufacturer information, country of origin (USA), and regulatory compliance data from the official Russia Roszdravnadzor medical device database. Pure Global AI offers free access to Russia's complete medical device registry, helping global MedTech companies navigate Roszdravnadzor regulations efficiently.