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Reagent for the identification of staphylococci in the plasma coagulation reaction "Rabbit citrate plasma dry" according to TU 21.20.23-008-96299156-2021 Options: I. Set No 1, consisting of: 1. Rabbit citrate plasma dry - 1 vial. 2. Instructions for use. 3. Quality passport. II. Set No 2, consisting of: 1. Rabbit citrate plasma dry - 10 vials. 2. Instructions for use. 3. Quality passport. III. Set No 3, consisting of: 1. Rabbit citrate plasma dry - 1 ampoule. 2. Instructions for use. 3. Quality passport. IV. Set No 4, consisting of: 1. Rabbit citrate plasma dry - 10 ampoules. 2. Instructions for use. 3. Quality passport. - Roszdravnadzor Registration РЗН 2022/17446

Access comprehensive regulatory information for Reagent for the identification of staphylococci in the plasma coagulation reaction "Rabbit citrate plasma dry" according to TU 21.20.23-008-96299156-2021 Options: I. Set No 1, consisting of: 1. Rabbit citrate plasma dry - 1 vial. 2. Instructions for use. 3. Quality passport. II. Set No 2, consisting of: 1. Rabbit citrate plasma dry - 10 vials. 2. Instructions for use. 3. Quality passport. III. Set No 3, consisting of: 1. Rabbit citrate plasma dry - 1 ampoule. 2. Instructions for use. 3. Quality passport. IV. Set No 4, consisting of: 1. Rabbit citrate plasma dry - 10 ampoules. 2. Instructions for use. 3. Quality passport. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2022/17446 and manufactured by OOO "BioHold". The device was registered on June 03, 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.

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Class 2b
РЗН 2022/17446
Reagent for the identification of staphylococci in the plasma coagulation reaction "Rabbit citrate plasma dry" according to TU 21.20.23-008-96299156-2021 Options: I. Set No 1, consisting of: 1. Rabbit citrate plasma dry - 1 vial. 2. Instructions for use. 3. Quality passport. II. Set No 2, consisting of: 1. Rabbit citrate plasma dry - 10 vials. 2. Instructions for use. 3. Quality passport. III. Set No 3, consisting of: 1. Rabbit citrate plasma dry - 1 ampoule. 2. Instructions for use. 3. Quality passport. IV. Set No 4, consisting of: 1. Rabbit citrate plasma dry - 10 ampoules. 2. Instructions for use. 3. Quality passport.
Реагент для идентификации стафилококков в реакции плазмокоагуляции "Плазма кроличья цитратная сухая" по ТУ 21.20.23-008-96299156-2021 варианты исполнения: I. Комплект № 1, в составе: 1. Плазма кроличья цитратная сухая - 1 флакон. 2. Инструкция по применению. 3. Паспорт качества. II. Комплект № 2, в составе: 1. Плазма кроличья цитратная сухая - 10 флаконов. 2. Инструкция по применению. 3. Паспорт качества. III. Комплект № 3, в составе: 1. Плазма кроличья цитратная сухая - 1 ампула. 2. Инструкция по применению. 3. Паспорт качества. IV. Комплект № 4, в составе: 1. Плазма кроличья цитратная сухая - 10 ампул. 2. Инструкция по применению. 3. Паспорт качества.
Roszdravnadzor Registration Number: РЗН 2022/17446
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Device Information
Device Name (English)
Reagent for the identification of staphylococci in the plasma coagulation reaction "Rabbit citrate plasma dry" according to TU 21.20.23-008-96299156-2021 Options: I. Set No 1, consisting of: 1. Rabbit citrate plasma dry - 1 vial. 2. Instructions for use. 3. Quality passport. II. Set No 2, consisting of: 1. Rabbit citrate plasma dry - 10 vials. 2. Instructions for use. 3. Quality passport. III. Set No 3, consisting of: 1. Rabbit citrate plasma dry - 1 ampoule. 2. Instructions for use. 3. Quality passport. IV. Set No 4, consisting of: 1. Rabbit citrate plasma dry - 10 ampoules. 2. Instructions for use. 3. Quality passport.
Device Name (Russian)
Реагент для идентификации стафилококков в реакции плазмокоагуляции "Плазма кроличья цитратная сухая" по ТУ 21.20.23-008-96299156-2021 варианты исполнения: I. Комплект № 1, в составе: 1. Плазма кроличья цитратная сухая - 1 флакон. 2. Инструкция по применению. 3. Паспорт качества. II. Комплект № 2, в составе: 1. Плазма кроличья цитратная сухая - 10 флаконов. 2. Инструкция по применению. 3. Паспорт качества. III. Комплект № 3, в составе: 1. Плазма кроличья цитратная сухая - 1 ампула. 2. Инструкция по применению. 3. Паспорт качества. IV. Комплект № 4, в составе: 1. Плазма кроличья цитратная сухая - 10 ампул. 2. Инструкция по применению. 3. Паспорт качества.
Device Type (English)
N/A
Device Type (Russian)
197770
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
79371.0
Registration Number
РЗН 2022/17446
Registration Date
June 03, 2024
Manufacturer Information
Manufacturer Name (English)
OOO "BioHold"
Manufacturer Name (Russian)
ООО "БиоХолд"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
LLC "NPP "DiaVita", Russia, 141074, Moscow region, Korolev, Pionerskaya str., 4, room. 203
Legal Address (Russian)
ООО "НПП "ДиаВита", Россия, 141074, Московская область, г. Королев, ул. Пионерская, д. 4, ком. 203
Manufacturing Address
111394, Россия, Москва, вн.тер.г. муниципальный округ Новогиреево, ул. Перовская, д. 61/2, стр. 1