Reagent kit for nucleic acid extraction from clinical material "Set NK-ex-AUTO-IMBIAN" as per TU 21.20.23-490-41390295-2023 Composed of: 1. 1-L-AUTO, 70 ml - 1 bottle. 2. 2-M, 3.0 ml - 1 bottle. 3. Proteinase K, 1.0 ml (after recovery) - 1 pc. 4. BP, 1.0 ml - 1 pc. 5. 3-W1-AUTO, 30 ml - 1 vial. 6. 4-W2, 100 ml - 1 bottle. 7. 5th, 10.0 ml - 1 bottle. 8. Passport - 1 pc. (provided as part of the delivery for each series of the product). 9. Instructions for use - 1 pc.
Russia·152850·IMBIAN LAB LLC·Registered May 21, 2024·N/A- Device Name (English)
- Reagent kit for nucleic acid extraction from clinical material "Set NK-ex-AUTO-IMBIAN" as per TU 21.20.23-490-41390295-2023 Composed of: 1. 1-L-AUTO, 70 ml - 1 bottle. 2. 2-M, 3.0 ml - 1 bottle. 3. Proteinase K, 1.0 ml (after recovery) - 1 pc. 4. BP, 1.0 ml - 1 pc. 5. 3-W1-AUTO, 30 ml - 1 vial. 6. 4-W2, 100 ml - 1 bottle. 7. 5th, 10.0 ml - 1 bottle. 8. Passport - 1 pc. (provided as part of the delivery for each series of the product). 9. Instructions for use - 1 pc.
- Device Name (Russian)
- Набор реагентов для экстракции нуклеиновых кислот из клинического материала "Комплект НК-ех-AUTO-ИМБИАН" по ТУ 21.20.23-490-41390295-2023 в составе: 1. 1-L-AUTO, 70 мл - 1 фл. 2. 2-М, 3,0 мл - 1 фл. 3. Протеиназа К, 1,0 мл (после воcстановления) - 1 пр. 4. БП, 1,0 мл - 1 пр. 5. 3-W1-AUTO, 30 мл - 1 фл. 6. 4-W2, 100 мл - 1 фл. 7. 5-Е, 10,0 мл - 1 фл. 8. Паспорт - 1 шт. (предоставляется в составе поставки на каждую серию изделия). 9. Инструкция по применению - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 152850
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 78209.0
- Registration Number
- РЗН 2024/22687
- Registration Date
- May 21, 2024
- Manufacturer Name (English)
- IMBIAN LAB LLC
- Manufacturer Name (Russian)
- ООО "ИМБИАН ЛАБ"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- IMBIAN LAB LLC, 13 Druzhby Narodov Street, Slavyansky District, Slavyansky, Krasnodar Region, 353560, Russian Federation
- Legal Address (Russian)
- ООО "ИМБИАН ЛАБ", Россия, 353560, Краснодарский край, р-н Славянский, г. Славянск-на-Кубани, ул. Дружбы Народов, д. 13
- Manufacturing Address
- 630559, Россия, Новосибирская область, г.о. рабочий посёлок Кольцово, р.п. Кольцово, ул. Садовая, д. 2/7, эт. 2, помещ. 2
Access comprehensive regulatory information for Reagent kit for nucleic acid extraction from clinical material "Set NK-ex-AUTO-IMBIAN" as per TU 21.20.23-490-41390295-2023 Composed of: 1. 1-L-AUTO, 70 ml - 1 bottle. 2. 2-M, 3.0 ml - 1 bottle. 3. Proteinase K, 1.0 ml (after recovery) - 1 pc. 4. BP, 1.0 ml - 1 pc. 5. 3-W1-AUTO, 30 ml - 1 vial. 6. 4-W2, 100 ml - 1 bottle. 7. 5th, 10.0 ml - 1 bottle. 8. Passport - 1 pc. (provided as part of the delivery for each series of the product). 9. Instructions for use - 1 pc. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2024/22687 and manufactured by IMBIAN LAB LLC. The device was registered on May 21, 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.