Set of calibrators for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+ calibrators" according to TU 21.20.23-114-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. Passport.
Russia·129040·NPF ABRIS+ LLC·Registered September 25, 2024·Class 2a- Device Name (English)
- Set of calibrators for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+ calibrators" according to TU 21.20.23-114-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. Passport.
- Device Name (Russian)
- Набор калибраторов для количественного определения содержания гликированного гемоглобина А1с в цельной крови иммунотурбидиметрическим методом "ГЛИКОГЕМОГЛОБИН КАЛИБРАТОРЫ АБРИС+" по ТУ 21.20.23-114-27428909-2024 в вариантах исполнения: I. Комплектация № 1 (конечный объем 0,5 мл), в составе: 1. Калибратор 1 - 1 фл. 2. Калибратор 2 - 1 фл. 3. Калибратор 3 - 1 фл. 4. Калибратор 4 - 1 фл. 5. Инструкция по применению. 6. Паспорт. II. Комплектация № 2 (конечный объем 1,0 мл), в составе: 1. Калибратор 1 - 1 фл. 2. Калибратор 2 - 1 фл. 3. Калибратор 3 - 1 фл. 4. Калибратор 4 - 1 фл. 5. Инструкция по применению. 6. Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 129040
- Risk Class
- Class 2a
- OKPD Code
- 20.59.52.195
- Registry Key
- 80794
- Registration Number
- РЗН 2024/23709
- Registration Date
- September 25, 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 Set of calibrators for quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN ABRIS+ calibrators" according to TU 21.20.23-114-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Calibrator 1 - 1 fl. 2. Calibrator 2 - 1 fl. 3. Calibrator 3 - 1 fl. 4. Calibrator 4 - 1 fl. 5. Instructions for use. 6. 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 2024/23709 and manufactured by NPF ABRIS+ LLC. The device was registered on September 25, 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.