Diagnostic reagent kits for immunological studies in vitro (see Appendix on 2 sheets) Reagent kits for determination: 1. Hepatitis B surface antigen - HBsAg 2. IgG antibodies to herpes of the first type - Herpes-Simplex Virus 1 (HSV1) IgG 3. IgG antibodies to herpes of the second type - Herpes-Simplex Virus 2 (HSV2) IgG 4. IgM antibodies to herpes of the first and second types - Herpes-Simplex Virus (HSV) IgM 5. IgG antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgG 6. IgM antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgM 7. IgG antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgG 8. IgM antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgM 9. Antibodies to HIV of the first and second types - Human Immunodeficience Virus (HIV) 1 + 2 10. IgG antibodies to rubella - Rubella IgG 11. IgM antibodies to rubella - Rubella IgM 12. Mumps IgG antibodies - Mumps IgG 13. Mumps IgM antibodies - Mumps IgM 14. IgG antibodies to measles - Measles IgG 15. IgM antibodies to measles - Measles IgM 16. IgG antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgG 17. IgM antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgM 18. IgG antibodies to Toxoplasma - Toxoplasma Gondii IgG 19. IgM antibodies to toxoplasma - Toxoplasma Gondii IgM 20. Reagin antibodies - Syphilis RPR 21. Antibodies to Treponema pallidum - Syphilis TPHA
Russia·Unknown·Human GmbH·Registered February 03, 2005·N/A- Device Name (English)
- Diagnostic reagent kits for immunological studies in vitro (see Appendix on 2 sheets) Reagent kits for determination: 1. Hepatitis B surface antigen - HBsAg 2. IgG antibodies to herpes of the first type - Herpes-Simplex Virus 1 (HSV1) IgG 3. IgG antibodies to herpes of the second type - Herpes-Simplex Virus 2 (HSV2) IgG 4. IgM antibodies to herpes of the first and second types - Herpes-Simplex Virus (HSV) IgM 5. IgG antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgG 6. IgM antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgM 7. IgG antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgG 8. IgM antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgM 9. Antibodies to HIV of the first and second types - Human Immunodeficience Virus (HIV) 1 + 2 10. IgG antibodies to rubella - Rubella IgG 11. IgM antibodies to rubella - Rubella IgM 12. Mumps IgG antibodies - Mumps IgG 13. Mumps IgM antibodies - Mumps IgM 14. IgG antibodies to measles - Measles IgG 15. IgM antibodies to measles - Measles IgM 16. IgG antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgG 17. IgM antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgM 18. IgG antibodies to Toxoplasma - Toxoplasma Gondii IgG 19. IgM antibodies to toxoplasma - Toxoplasma Gondii IgM 20. Reagin antibodies - Syphilis RPR 21. Antibodies to Treponema pallidum - Syphilis TPHA
- Device Name (Russian)
- Наборы реагентов диагностических для иммунологических исследований in vitro (см. Приложение на 2 листах) Наборы реагентов для определения: 1. Поверхностного антигена гепатита В - HBsAg 2. Антител IgG к герпесу первого типа - Herpes-Simplex Virus 1 (HSV1) IgG 3. Антител IgG к герпесу второго типа - Herpes-Simplex Virus 2 (HSV2) IgG 4. Антител IgM к герпесу первого и второго типов - Herpes-Simplex Virus (HSV) IgM 5. Антител IgG к вирусу Varicella-Zoster - Varicella-Zoster Virus (VZV) IgG 6. Антител IgM к вирусу Varicella-Zoster - Varicella-Zoster Virus (VZV) IgM 7. Антител IgG к вирусу Epstein-Barr - Epstein-Barr Virus (EBV) IgG 8. Антител IgM к вирусу Epstein-Barr - Epstein-Barr Virus (EBV) IgM 9. Антител к ВИЧ первого и второго типов - Human Immunodeficience Virus (HIV) 1+2 10. Антител IgG к краснухе - Rubella IgG 11. Антител IgM к краснухе - Rubella IgM 12. Антител IgG к паротиту - Mumps IgG 13. Антител IgM к паротиту - Mumps IgM 14. Антител IgG к кори - Measles IgG 15. Антител IgM к кори - Measles IgM 16. Антител IgG к цитомегаловирусу - Cytomegalovirus (CMV) IgG 17. Антител IgM к цитомегаловирусу - Cytomegalovirus (CMV) IgM 18. Антител IgG к токсоплазме - Toxoplasma Gondii IgG 19. Антител IgM к токсоплазме - Toxoplasma Gondii IgM 20. Реагиновых антител - Syphilis RPR 21. Антител к Treponema pallidum - Syphilis TPHA
- Device Type (English)
- N/A
- Device Type (Russian)
- Unknown
- Risk Class
- N/A
- Registry Key
- o66999
- Registration Number
- ФС № 2005/172
- Registration Date
- February 03, 2005
- Validity Period
- February 03, 2010
- Manufacturer Name (English)
- Human GmbH
- Manufacturer Name (Russian)
- Human GmbH
- Country (English)
- GERMANY
- Country (Russian)
- ФРГ
- Legal Address (English)
- GERMANY
- Legal Address (Russian)
- ФРГ
Access comprehensive regulatory information for Diagnostic reagent kits for immunological studies in vitro (see Appendix on 2 sheets) Reagent kits for determination: 1. Hepatitis B surface antigen - HBsAg 2. IgG antibodies to herpes of the first type - Herpes-Simplex Virus 1 (HSV1) IgG 3. IgG antibodies to herpes of the second type - Herpes-Simplex Virus 2 (HSV2) IgG 4. IgM antibodies to herpes of the first and second types - Herpes-Simplex Virus (HSV) IgM 5. IgG antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgG 6. IgM antibodies to the Varicella-Zoster virus - Varicella-Zoster Virus (VZV) IgM 7. IgG antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgG 8. IgM antibodies to the Epstein-Barr virus - Epstein-Barr Virus (EBV) IgM 9. Antibodies to HIV of the first and second types - Human Immunodeficience Virus (HIV) 1 + 2 10. IgG antibodies to rubella - Rubella IgG 11. IgM antibodies to rubella - Rubella IgM 12. Mumps IgG antibodies - Mumps IgG 13. Mumps IgM antibodies - Mumps IgM 14. IgG antibodies to measles - Measles IgG 15. IgM antibodies to measles - Measles IgM 16. IgG antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgG 17. IgM antibodies to cytomegalovirus - Cytomegalovirus (CMV) IgM 18. IgG antibodies to Toxoplasma - Toxoplasma Gondii IgG 19. IgM antibodies to toxoplasma - Toxoplasma Gondii IgM 20. Reagin antibodies - Syphilis RPR 21. Antibodies to Treponema pallidum - Syphilis TPHA in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФС № 2005/172 and manufactured by Human GmbH. The device was registered on February 03, 2005.
This page provides complete registration details including device type, manufacturer information, country of origin (GERMANY), 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.