Reagent kit for quantitative enzyme-linked immunosorbent determination of 25-OH of vitamin D in human blood serum "25-OH vitamin D-Imaxiz (IMAXYZ)", TU 21.20.23-116-94568735-2021 Composed of: - microplate - 1 package; - Conjugate - 1 vial (14 ml); - calibration samples - 6 vials (0.5 ml each); - control serum - 1 vial (0.5 ml); - Buffer A - 1 vial (14 ml); - DN buffer - 1 vial (14 ml); - TMB solution - 1 vial (14 ml); - stop reagent - 1 vial (14 ml); - Buffer P - 1 vial (50 ml); - resealable bag - 1 pc.; - film for gluing a microplate - 2 pcs.; - baths for applying reagents - 2 pcs.; - disposable tips for dispensers - 16 pcs.
Russia·194260·Vital Development Corporation JSC·Registered June 08, 2022·Class 2a- Device Name (English)
- Reagent kit for quantitative enzyme-linked immunosorbent determination of 25-OH of vitamin D in human blood serum "25-OH vitamin D-Imaxiz (IMAXYZ)", TU 21.20.23-116-94568735-2021 Composed of: - microplate - 1 package; - Conjugate - 1 vial (14 ml); - calibration samples - 6 vials (0.5 ml each); - control serum - 1 vial (0.5 ml); - Buffer A - 1 vial (14 ml); - DN buffer - 1 vial (14 ml); - TMB solution - 1 vial (14 ml); - stop reagent - 1 vial (14 ml); - Buffer P - 1 vial (50 ml); - resealable bag - 1 pc.; - film for gluing a microplate - 2 pcs.; - baths for applying reagents - 2 pcs.; - disposable tips for dispensers - 16 pcs.
- Device Name (Russian)
- Набор реагентов для количественного иммуноферментного определения 25-ОН витамина D в сыворотке крови человека "25-ОН витамин D-Имаксиз (IMAXYZ)", ТУ 21.20.23-116-94568735-2021 в составе: - микропланшет - 1 упаковка; - конъюгат - 1 флакон (14 мл); - калибровочные пробы - 6 флаконов (по 0,5 мл); - контрольная сыворотка - 1 флакон (0,5 мл); - буфер А - 1 флакон (14 мл); - буфер ДН - 1 флакон (14 мл); - раствор ТМБ - 1 флакон (14 мл); - стоп-реагент - 1 флакон (14 мл); - Буфер П - 1 флакон (50 мл); - пакет закрывающийся - 1 шт.; - пленка для заклеивания микропланшета - 2 шт.; - ванночки для внесения реагентов - 2 шт.; - одноразовые наконечники для дозаторов - 16 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 194260
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 62261.0
- Registration Number
- РЗН 2022/17493
- Registration Date
- June 08, 2022
- 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 25-OH of vitamin D in human blood serum "25-OH vitamin D-Imaxiz (IMAXYZ)", TU 21.20.23-116-94568735-2021 Composed of: - microplate - 1 package; - Conjugate - 1 vial (14 ml); - calibration samples - 6 vials (0.5 ml each); - control serum - 1 vial (0.5 ml); - Buffer A - 1 vial (14 ml); - DN buffer - 1 vial (14 ml); - TMB solution - 1 vial (14 ml); - stop reagent - 1 vial (14 ml); - Buffer P - 1 vial (50 ml); - resealable bag - 1 pc.; - film for gluing a microplate - 2 pcs.; - baths for applying reagents - 2 pcs.; - disposable tips for dispensers - 16 pcs. 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 2022/17493 and manufactured by Vital Development Corporation JSC. The device was registered on June 08, 2022.
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.