Russia Roszdravnadzor registration РЗН 2024/22685

Reagent kit for nucleic acid extraction from clinical material "NK-EX-IMBIAN set" as per TU 21.20.23-491-41390295-2023 Composed of: Set NK-EX-IMBIAN: 1. 1-L, 70 ml - 1 vial. 2. 2-SU, 3.0 ml - 1 vial. 3. 3-W1.30 ml - 1 bottle. 4. 4-W2, 100 ml - 1 fl. 5. 5th, 10.0 ml - 1 bottle. 6. Passport - 1 pc. (provided as part of the delivery for each series of the product). 7. Instructions for use - 1 pc.

RU: Набор реагентов для экстракции нуклеиновых кислот из клинического материала "Комплект НК-EX-ИМБИАН" по ТУ 21.20.23-491-41390295-2023 в составе: Комплект НК-ех-ИМБИАН: 1. 1-L, 70 мл - 1 фл. 2. 2-СУ, 3,0 мл - 1 фл. 3. 3-W1,30 мл - 1 фл. 4. 4-W2, 100 мл - 1 фл. 5. 5-Е, 10,0 мл - 1 фл. 6. Паспорт - 1 шт. (предоставляется в составе поставки на каждую серию изделия). 7. Инструкция по применению - 1 шт.
Russia flagRussia·152850·IMBIAN LAB LLC·Registered May 21, 2024·N/A
Device information
Device Name (English)
Reagent kit for nucleic acid extraction from clinical material "NK-EX-IMBIAN set" as per TU 21.20.23-491-41390295-2023 Composed of: Set NK-EX-IMBIAN: 1. 1-L, 70 ml - 1 vial. 2. 2-SU, 3.0 ml - 1 vial. 3. 3-W1.30 ml - 1 bottle. 4. 4-W2, 100 ml - 1 fl. 5. 5th, 10.0 ml - 1 bottle. 6. Passport - 1 pc. (provided as part of the delivery for each series of the product). 7. Instructions for use - 1 pc.
Device Name (Russian)
Набор реагентов для экстракции нуклеиновых кислот из клинического материала "Комплект НК-EX-ИМБИАН" по ТУ 21.20.23-491-41390295-2023 в составе: Комплект НК-ех-ИМБИАН: 1. 1-L, 70 мл - 1 фл. 2. 2-СУ, 3,0 мл - 1 фл. 3. 3-W1,30 мл - 1 фл. 4. 4-W2, 100 мл - 1 фл. 5. 5-Е, 10,0 мл - 1 фл. 6. Паспорт - 1 шт. (предоставляется в составе поставки на каждую серию изделия). 7. 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
78219.0
Registration Number
РЗН 2024/22685
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
About this record

Access comprehensive regulatory information for Reagent kit for nucleic acid extraction from clinical material "NK-EX-IMBIAN set" as per TU 21.20.23-491-41390295-2023 Composed of: Set NK-EX-IMBIAN: 1. 1-L, 70 ml - 1 vial. 2. 2-SU, 3.0 ml - 1 vial. 3. 3-W1.30 ml - 1 bottle. 4. 4-W2, 100 ml - 1 fl. 5. 5th, 10.0 ml - 1 bottle. 6. Passport - 1 pc. (provided as part of the delivery for each series of the product). 7. 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 2024/22685 and manufactured by IMBIAN LAB LLC. The device was registered on May 21, 2024.

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