Reagent kit for quantitative enzyme-linked immunosorbent determination of sex-steroid-binding globulin in human serum "CCG-Imaxiz (IMAXYZ)", TU 21.20.23-119-94568735-2023 Composed of: 1. Microplate with antibodies to SSH - 1 package. 2. Conjugate - 1 vial (14 ml). 3. A set of calibration samples NoNo 1-6-b vials (0.5 ml each). 4. Control serum - 1 vial (0.5 ml). 5. Buffer P - 1 vial (50 ml). 6. TMB solution - 1 vial (14 ml). 7. Stop reagent - 1 vial (14 ml). 8. Buffer P - 1 vial (20 ml). 9. Resealable bag - 1 pc. 10. Film for gluing a microplate - 1 pc. 11. Baths for applying reagents - 2 pcs. 12. Disposable tips for dispensers - 16 pcs. 13. Instructions for use - 1 pc. 14. Passport.
Russia·176150·Vital Development Corporation JSC·Registered September 07, 2023·Class 2a- Device Name (English)
- Reagent kit for quantitative enzyme-linked immunosorbent determination of sex-steroid-binding globulin in human serum "CCG-Imaxiz (IMAXYZ)", TU 21.20.23-119-94568735-2023 Composed of: 1. Microplate with antibodies to SSH - 1 package. 2. Conjugate - 1 vial (14 ml). 3. A set of calibration samples NoNo 1-6-b vials (0.5 ml each). 4. Control serum - 1 vial (0.5 ml). 5. Buffer P - 1 vial (50 ml). 6. TMB solution - 1 vial (14 ml). 7. Stop reagent - 1 vial (14 ml). 8. Buffer P - 1 vial (20 ml). 9. Resealable bag - 1 pc. 10. Film for gluing a microplate - 1 pc. 11. Baths for applying reagents - 2 pcs. 12. Disposable tips for dispensers - 16 pcs. 13. Instructions for use - 1 pc. 14. Passport.
- Device Name (Russian)
- Набор реагентов для количественного иммуноферментного определения секс-стероидсвязывающего глобулина в сыворотке крови человека "CCГ-Имаксиз (IMAXYZ)", ТУ 21.20.23-119-94568735-2023 в составе: 1. Микропланшет с антителами к ССГ - 1 упаковка. 2. Конъюгат - 1 флакон (14 мл). 3. Комплект калибровочных проб №№ 1-6- б флаконов (по 0,5 мл). 4. Контрольная сыворотка - 1 флакон (0,5 мл). 5. Буфер Р - 1 флакон (50 мл). 6. Раствор ТМБ - 1 флакон (14 мл). 7. Стоп-реагент - 1 флакон (14 мл). 8. Буфер П - 1 флакон (20 мл). 9. Пакет закрывающийся - 1 шт. 10. Пленка для заклеивания микропланшета - 1 шт. 11. Ванночки для внесения реагентов - 2 шт. 12. Одноразовые наконечники для дозаторов - 16 шт. 13. Инструкция по применению - 1 шт. 14. Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 176150
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 71579.0
- Registration Number
- РЗН 2023/21049
- Registration Date
- September 07, 2023
- Manufacturer Name (English)
- Vital Development Corporation JSC
- Manufacturer Name (Russian)
- АО "Витал Девелопмент Корпорэйшн"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- JSC "Vital Development Corporation", Russia, 194356, St. Petersburg, Road to Kamenka, 56, lit. And
- Legal Address (Russian)
- АО "Витал Девелопмент Корпорэйшн", Россия, 194356, Санкт-Петербург, Дорога в Каменку, д. 56, лит. А
- Manufacturing Address
- 194356, Россия, Санкт-Петербург, Дорога в Каменку, д. 56, лит. А
Access comprehensive regulatory information for Reagent kit for quantitative enzyme-linked immunosorbent determination of sex-steroid-binding globulin in human serum "CCG-Imaxiz (IMAXYZ)", TU 21.20.23-119-94568735-2023 Composed of: 1. Microplate with antibodies to SSH - 1 package. 2. Conjugate - 1 vial (14 ml). 3. A set of calibration samples NoNo 1-6-b vials (0.5 ml each). 4. Control serum - 1 vial (0.5 ml). 5. Buffer P - 1 vial (50 ml). 6. TMB solution - 1 vial (14 ml). 7. Stop reagent - 1 vial (14 ml). 8. Buffer P - 1 vial (20 ml). 9. Resealable bag - 1 pc. 10. Film for gluing a microplate - 1 pc. 11. Baths for applying reagents - 2 pcs. 12. Disposable tips for dispensers - 16 pcs. 13. Instructions for use - 1 pc. 14. Passport. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2023/21049 and manufactured by Vital Development Corporation JSC. The device was registered on September 07, 2023.
This page provides complete registration details including device type, manufacturer information, country of origin (Russia), 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.