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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. - Roszdravnadzor Registration РЗН 2024/22687

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.

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Roszdravnadzor Official Data
N/A
РЗН 2024/22687
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.
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.
Roszdravnadzor Registration Number: РЗН 2024/22687
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Device Information
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
Registration Information
Registry Key
78209.0
Registration Number
РЗН 2024/22687
Registration Date
May 21, 2024
Manufacturer Information
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