Reagent kit for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+" according to TU 21.20.23-113-27428909-2024 In versions: Configuration No1, consisting of: - reagent 1 -1 vial. (30 ml); - reagent 2 - 1 vial. (10 ml); - Reagent 3 (lysis reagent) - 1 fl. (100 ml); - instructions for use; -passport. Configuration No2, consisting of: - reagent 1 -1 vial. (45 ml); - reagent 2 - 1 vial. (15 ml); - reagent 3 (lysis reagent) - 2 vials. (100 ml); - instructions for use; -passport. Configuration No3, consisting of: - reagent 1 - 2 vials. (43.5 ml each); - reagent 2 - 2 vials. (14.5 ml); - Reagent 3 (lysis reagent) - 4 vials. (100 ml); - instructions for use; -passport. Configuration No4, consisting of: - reagent 1 - 4 vials. (15 ml); - reagent 2 - 4 vials. (5 ml each); - Reagent 3 (lysis reagent) - 3 vials. (100 ml); - instructions for use; -passport.
Russia·128860·NPF ABRIS+ LLC·Registered September 23, 2024·Class 2a- Device Name (English)
- Reagent kit for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+" according to TU 21.20.23-113-27428909-2024 In versions: Configuration No1, consisting of: - reagent 1 -1 vial. (30 ml); - reagent 2 - 1 vial. (10 ml); - Reagent 3 (lysis reagent) - 1 fl. (100 ml); - instructions for use; -passport. Configuration No2, consisting of: - reagent 1 -1 vial. (45 ml); - reagent 2 - 1 vial. (15 ml); - reagent 3 (lysis reagent) - 2 vials. (100 ml); - instructions for use; -passport. Configuration No3, consisting of: - reagent 1 - 2 vials. (43.5 ml each); - reagent 2 - 2 vials. (14.5 ml); - Reagent 3 (lysis reagent) - 4 vials. (100 ml); - instructions for use; -passport. Configuration No4, consisting of: - reagent 1 - 4 vials. (15 ml); - reagent 2 - 4 vials. (5 ml each); - Reagent 3 (lysis reagent) - 3 vials. (100 ml); - instructions for use; -passport.
- Device Name (Russian)
- Набор реагентов для количественного определения содержания гликированного гемоглобина А1с в цельной крови иммунотурбидиметрическим методом "ГЛИКОГЕМОГЛОБИН АБРИС+" по ТУ 21.20.23-113-27428909-2024 в вариантах исполнения: Комплектация №1, в составе: - реагент 1 -1 фл. (30 мл); - реагент 2 - 1 фл. (10 мл); - реагент 3 (лизирующий реагент) - 1 фл. (100 мл); - инструкция по применению; - паспорт. Комплектация №2, в составе: - реагент 1 -1 фл. (45 мл); - реагент 2 - 1 фл. (15 мл); - реагент 3 (лизирующий реагент) - 2 фл. (по 100 мл); - инструкция по применению; - паспорт. Комплектация №3, в составе: - реагент 1 - 2 фл. (по 43,5 мл); - реагент 2 - 2 фл. (по 14,5 мл); - реагент 3 (лизирующий реагент) - 4 фл. (по 100 мл); - инструкция по применению; - паспорт. Комплектация №4, в составе: - реагент 1 - 4 фл. (по 15 мл); - реагент 2 - 4 фл. (по 5 мл); - реагент 3 (лизирующий реагент) - 3 фл. (по 100 мл); - инструкция по применению; - паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 128860
- Risk Class
- Class 2a
- OKPD Code
- 20.59.52.195
- Registry Key
- 80791
- Registration Number
- РЗН 2024/23684
- Registration Date
- September 23, 2024
- Manufacturer Name (English)
- NPF ABRIS+ LLC
- Manufacturer Name (Russian)
- ООО "НПФ "АБРИС+"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NPF ABRIS+ LLC, St. Petersburg, 192019, Russia, Professor Kachalova str., 15a, lit. And
- Legal Address (Russian)
- ООО "НПФ "АБРИС+", Россия, 192019, Санкт-Петербург, ул. Профессора Качалова, д. 15а, лит. А
- Manufacturing Address
- 196006, Россия, Санкт-Петербург, ул. Цветочная, д. 16, лит. М, эт. 2
Access comprehensive regulatory information for Reagent kit for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+" according to TU 21.20.23-113-27428909-2024 In versions: Configuration No1, consisting of: - reagent 1 -1 vial. (30 ml); - reagent 2 - 1 vial. (10 ml); - Reagent 3 (lysis reagent) - 1 fl. (100 ml); - instructions for use; -passport. Configuration No2, consisting of: - reagent 1 -1 vial. (45 ml); - reagent 2 - 1 vial. (15 ml); - reagent 3 (lysis reagent) - 2 vials. (100 ml); - instructions for use; -passport. Configuration No3, consisting of: - reagent 1 - 2 vials. (43.5 ml each); - reagent 2 - 2 vials. (14.5 ml); - Reagent 3 (lysis reagent) - 4 vials. (100 ml); - instructions for use; -passport. Configuration No4, consisting of: - reagent 1 - 4 vials. (15 ml); - reagent 2 - 4 vials. (5 ml each); - Reagent 3 (lysis reagent) - 3 vials. (100 ml); - instructions for use; -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 2024/23684 and manufactured by NPF ABRIS+ LLC. The device was registered on September 23, 2024.
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.