Reagent kit for the detection and semi-quantitative determination of total antibodies to Treponema pallidum in the microprecipitation reaction "Cardiolipin Antigen - RMP" according to TU 21.20.23-007-96299156-2020 In versions: I. Set 1, consisting of: 1. Cardiolipin antigen (ACL) 2.0 ml - 5 ampoules. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. II. Set 2, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 ampoules. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. Quality passport. III. Set 3, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 5 vials. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. IV. Set 4, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 vials. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. Quality passport.
Russia·244360·OOO "BioHold"·Registered June 03, 2024·Class 2b- Device Name (English)
- Reagent kit for the detection and semi-quantitative determination of total antibodies to Treponema pallidum in the microprecipitation reaction "Cardiolipin Antigen - RMP" according to TU 21.20.23-007-96299156-2020 In versions: I. Set 1, consisting of: 1. Cardiolipin antigen (ACL) 2.0 ml - 5 ampoules. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. II. Set 2, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 ampoules. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. Quality passport. III. Set 3, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 5 vials. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. IV. Set 4, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 vials. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. Quality passport.
- Device Name (Russian)
- Набор реагентов для выявления и полуколичественного определения суммарных антител к Treponema pallidum в реакции микропреципитации «Антиген кардиолипиновый - РМП» по ТУ 21.20.23-007-96299156-2020 в вариантах исполнения: I. Комплект 1, в составе: 1. Антиген кардиолипиновый (АГКЛ) 2,0 мл - 5 ампул. 2. Раствор холин-хлорида 5,0 мл - 1 флакон. 3. Инструкция по применению. 4. Паспорт качества. II. Комплект 2, в составе: 1. Антиген кардиолипиновый (АГКЛ) 2,0 мл - 10 ампул. 2. Раствор холин-хлорида 5,0 мл - 2 флакона. 3. Инструкция по применению. 4. Паспорт качества. III. Комплект 3, в составе: 1. Антиген кардиолипиновый (АГКЛ) 2,0 мл - 5 флаконов. 2. Раствор холин-хлорида 5,0 мл - 1 флакон. 3. Инструкция по применению. 4. Паспорт качества. IV. Комплект 4, в составе: 1. Антиген кардиолипиновый (АГКЛ) 2,0 мл - 10 флаконов. 2. Раствор холин-хлорида 5,0 мл - 2 флакона. 3. Инструкция по применению. 4. Паспорт качества.
- Device Type (English)
- N/A
- Device Type (Russian)
- 244360
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 79361.0
- Registration Number
- РЗН 2021/15528
- Registration Date
- June 03, 2024
- Manufacturer Name (English)
- OOO "BioHold"
- Manufacturer Name (Russian)
- ООО "БиоХолд"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NPP DiaVita LLC, Pionerskaya st., 4, room 203, Korolev, Moscow region, 141074 Russia
- Legal Address (Russian)
- ООО "НПП "ДиаВита", Россия, 141074, Московская область, г. Королев, ул. Пионерская, д. 4, к. 203
- Manufacturing Address
- 111394, Россия, Москва, вн.тер.г. муниципальный округ Новогиреево, ул. Перовская, д. 61/2, стр. 1
Access comprehensive regulatory information for Reagent kit for the detection and semi-quantitative determination of total antibodies to Treponema pallidum in the microprecipitation reaction "Cardiolipin Antigen - RMP" according to TU 21.20.23-007-96299156-2020 In versions: I. Set 1, consisting of: 1. Cardiolipin antigen (ACL) 2.0 ml - 5 ampoules. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. II. Set 2, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 ampoules. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. Quality passport. III. Set 3, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 5 vials. 2. Choline chloride solution 5.0 ml - 1 vial. 3. Instructions for use. 4. Quality passport. IV. Set 4, consisting of: 1. Cardiolipin antigen (AGCL) 2.0 ml - 10 vials. 2. Choline chloride solution 5.0 ml - 2 vials. 3. Instructions for use. 4. 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 2021/15528 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.