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Reagent kit for the detection and semi-quantitative determination of tetanus antitoxin in the passive hemagglutination reaction "Diagnosticum tetanus-RPGA" TU 21.20.23-011-96299156-2021 Composed of: 1. Diagnosticum erythrocyte tetanus 5.0 ml - 2 vials. 2. Ram erythrocytes formalized 50% 5.0 ml - 2 vials. 3. Sheep erythrocytes control 5.0 ml -1 vial. 4. Phosphate buffer solution (FBI) 3.2 ml - 4 vials. 5. Phosphate-buffered solution (FBI) with twin 6.4 ml - 4 vials. 6. Anti-tetanus control serum 1.0 ml -1 vial. 7. Instructions for use. 8. Quality passport. - Roszdravnadzor Registration РЗН 2022/16341

Access comprehensive regulatory information for Reagent kit for the detection and semi-quantitative determination of tetanus antitoxin in the passive hemagglutination reaction "Diagnosticum tetanus-RPGA" TU 21.20.23-011-96299156-2021 Composed of: 1. Diagnosticum erythrocyte tetanus 5.0 ml - 2 vials. 2. Ram erythrocytes formalized 50% 5.0 ml - 2 vials. 3. Sheep erythrocytes control 5.0 ml -1 vial. 4. Phosphate buffer solution (FBI) 3.2 ml - 4 vials. 5. Phosphate-buffered solution (FBI) with twin 6.4 ml - 4 vials. 6. Anti-tetanus control serum 1.0 ml -1 vial. 7. Instructions for use. 8. 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 2022/16341 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 2022/16341
Reagent kit for the detection and semi-quantitative determination of tetanus antitoxin in the passive hemagglutination reaction "Diagnosticum tetanus-RPGA" TU 21.20.23-011-96299156-2021 Composed of: 1. Diagnosticum erythrocyte tetanus 5.0 ml - 2 vials. 2. Ram erythrocytes formalized 50% 5.0 ml - 2 vials. 3. Sheep erythrocytes control 5.0 ml -1 vial. 4. Phosphate buffer solution (FBI) 3.2 ml - 4 vials. 5. Phosphate-buffered solution (FBI) with twin 6.4 ml - 4 vials. 6. Anti-tetanus control serum 1.0 ml -1 vial. 7. Instructions for use. 8. Quality passport.
Набор реагентов для выявления и полуколичественного определения столбнячного антитоксина в реакции пассивной гемагглютинации "Диагностикум столбнячный-РПГА" ТУ 21.20.23-011-96299156-2021 в составе: 1. Диагностикум эритроцитарный столбнячный 5,0 мл - 2 флакона. 2. Эритроциты барана формалинизированные 50% 5,0 мл - 2 флакона. 3. Эритроциты барана контрольные 5,0 мл -1 флакон. 4. Фосфатно-буферный раствор (ФБР) 3,2 мл - 4 флакона. 5. Фосфатно-буферный раствор (ФБР) с твином 6,4 мл - 4 флакона. 6. Сыворотка противостолбнячная контрольная 1,0 мл -1 флакон. 7. Инструкция по применению. 8. Паспорт качества.
Roszdravnadzor Registration Number: РЗН 2022/16341
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Device Information
Device Name (English)
Reagent kit for the detection and semi-quantitative determination of tetanus antitoxin in the passive hemagglutination reaction "Diagnosticum tetanus-RPGA" TU 21.20.23-011-96299156-2021 Composed of: 1. Diagnosticum erythrocyte tetanus 5.0 ml - 2 vials. 2. Ram erythrocytes formalized 50% 5.0 ml - 2 vials. 3. Sheep erythrocytes control 5.0 ml -1 vial. 4. Phosphate buffer solution (FBI) 3.2 ml - 4 vials. 5. Phosphate-buffered solution (FBI) with twin 6.4 ml - 4 vials. 6. Anti-tetanus control serum 1.0 ml -1 vial. 7. Instructions for use. 8. Quality passport.
Device Name (Russian)
Набор реагентов для выявления и полуколичественного определения столбнячного антитоксина в реакции пассивной гемагглютинации "Диагностикум столбнячный-РПГА" ТУ 21.20.23-011-96299156-2021 в составе: 1. Диагностикум эритроцитарный столбнячный 5,0 мл - 2 флакона. 2. Эритроциты барана формалинизированные 50% 5,0 мл - 2 флакона. 3. Эритроциты барана контрольные 5,0 мл -1 флакон. 4. Фосфатно-буферный раствор (ФБР) 3,2 мл - 4 флакона. 5. Фосфатно-буферный раствор (ФБР) с твином 6,4 мл - 4 флакона. 6. Сыворотка противостолбнячная контрольная 1,0 мл -1 флакон. 7. Инструкция по применению. 8. Паспорт качества.
Device Type (English)
N/A
Device Type (Russian)
342490
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
79362.0
Registration Number
РЗН 2022/16341
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