Pure Global

Set of control materials for quality control of quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN CONTROL ABRIS+" according to TU 21.20.23-115-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport. - Roszdravnadzor Registration РЗН 2024/23708

Access comprehensive regulatory information for Set of control materials for quality control of quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN CONTROL ABRIS+" according to TU 21.20.23-115-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. 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 2024/23708 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.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2a
РЗН 2024/23708
Set of control materials for quality control of quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN CONTROL ABRIS+" according to TU 21.20.23-115-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport.
Набор контрольных материалов для контроля качества количественного определения содержания гликированного гемоглобина А1с в цельной крови иммунотурбидиметрическим методом "ГЛИКОГЕМОГЛОБИН КОНТРОЛИ АБРИС+" по ТУ 21.20.23-115-27428909-2024 в вариантах исполнения: I. Комплектация № 1 (конечный объем 0,5 мл), в составе: 1. Контроль 1 - 1 фл. 2. Контроль 2 - 1 фл. 3. Инструкция по применению. 4. Паспорт. II. Комплектация № 2 (конечный объем 1,0 мл), в составе: 1. Контроль 1 - 1 фл. 2. Контроль 2 - 1 фл. 3. Инструкция по применению. 4. Паспорт.
Roszdravnadzor Registration Number: РЗН 2024/23708
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
Set of control materials for quality control of quantitative determination of glycated hemoglobin A1c content in whole blood by immunoturbidimetric method "GLYCOHEMOGLOBIN CONTROL ABRIS+" according to TU 21.20.23-115-27428909-2024 In versions: I. Complete set No 1 (final volume 0.5 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport. II. Complete set No 2 (final volume 1.0 ml), consisting of: 1. Control 1 - 1 fl. 2. Control 2 - 1 fl. 3. Instructions for use. 4. Passport.
Device Name (Russian)
Набор контрольных материалов для контроля качества количественного определения содержания гликированного гемоглобина А1с в цельной крови иммунотурбидиметрическим методом "ГЛИКОГЕМОГЛОБИН КОНТРОЛИ АБРИС+" по ТУ 21.20.23-115-27428909-2024 в вариантах исполнения: I. Комплектация № 1 (конечный объем 0,5 мл), в составе: 1. Контроль 1 - 1 фл. 2. Контроль 2 - 1 фл. 3. Инструкция по применению. 4. Паспорт. II. Комплектация № 2 (конечный объем 1,0 мл), в составе: 1. Контроль 1 - 1 фл. 2. Контроль 2 - 1 фл. 3. Инструкция по применению. 4. Паспорт.
Device Type (English)
N/A
Device Type (Russian)
129050
Risk Class
Class 2a
OKPD Code
20.59.52.195
Registration Information
Registry Key
80792
Registration Number
РЗН 2024/23708
Registration Date
September 25, 2024
Manufacturer Information
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