Rapid test for qualitative immunochromatographic determination of respiratory syncytial virus and/or influenza A and B antigens in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023 Options: I. Set No1: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 pc. - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 1 pc.; - Instructions for use - 1 pc. II. Set No2: - Test cassette - 20 pcs.; - Buffer solution, 1.0 ml - 20 pcs.; - Sterile swab probe MiniMed TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 20 pcs.; - Instructions for use - 1 pc. III. Set No3: - Test cassette - 25 pcs.; - Buffer solution, 1.0 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 25 pcs.; - Instructions for use - 1 pc. Scope of delivery: 1. Rapid test for qualitative immunochromatographic determination of antigens of respiratory syncytial virus and/or influenza A and B in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023. 2. Passport - 1 pc. (provided as part of the delivery for each series of products). - Roszdravnadzor Registration РЗН 2024/22145

Access comprehensive regulatory information for Rapid test for qualitative immunochromatographic determination of respiratory syncytial virus and/or influenza A and B antigens in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023 Options: I. Set No1: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 pc. - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 1 pc.; - Instructions for use - 1 pc. II. Set No2: - Test cassette - 20 pcs.; - Buffer solution, 1.0 ml - 20 pcs.; - Sterile swab probe MiniMed TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 20 pcs.; - Instructions for use - 1 pc. III. Set No3: - Test cassette - 25 pcs.; - Buffer solution, 1.0 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 25 pcs.; - Instructions for use - 1 pc. Scope of delivery: 1. Rapid test for qualitative immunochromatographic determination of antigens of respiratory syncytial virus and/or influenza A and B in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023. 2. Passport - 1 pc. (provided as part of the delivery for each series of products). 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 2024/22145 and manufactured by IMBIAN LLC. The device was registered on March 04, 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

Class 2b

РЗН 2024/22145

Rapid test for qualitative immunochromatographic determination of respiratory syncytial virus and/or influenza A and B antigens in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023 Options: I. Set No1: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 pc. - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 1 pc.; - Instructions for use - 1 pc. II. Set No2: - Test cassette - 20 pcs.; - Buffer solution, 1.0 ml - 20 pcs.; - Sterile swab probe MiniMed TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 20 pcs.; - Instructions for use - 1 pc. III. Set No3: - Test cassette - 25 pcs.; - Buffer solution, 1.0 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020: plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079, manufactured by MiniMed LLC, Russia) - 25 pcs.; - Instructions for use - 1 pc. Scope of delivery: 1. Rapid test for qualitative immunochromatographic determination of antigens of respiratory syncytial virus and/or influenza A and B in respiratory secretions "RSV/INFLUENZA A + B-IMBIAN-IHA" according to TU 21.20.23-072-39271034-2023. 2. Passport - 1 pc. (provided as part of the delivery for each series of products).

Экспресс-тест для качественного иммунохроматографического определения антигенов респираторно-синцитиального вируса и/или гриппа А и В в респираторных выделениях "RSV/ГРИПП А+В-ИМБИАН-ИХА" по ТУ 21.20.23-072-39271034-2023 Варианты исполнения: I. Комплект №1: - Тест-кассета - 1 шт.; - Буферный раствор, 1,0 мл - 1 пр. - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020: зонд пластиковый (полипропилен), тампон хлопковый, длина: 150 мм (РУ № РЗН 2021/15079, производства ООО "МиниМед", Россия) - 1 шт.; - Инструкция по применению - 1 шт. II. Комплект №2: - Тест-кассета - 20 шт.; - Буферный раствор, 1,0 мл - 20 пр.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020: зонд пластиковый (полипропилен), тампон хлопковый, длина: 150 мм (РУ № РЗН 2021/15079, производства ООО "МиниМед", Россия) - 20 шт.; - Инструкция по применению - 1 шт. III. Комплект №3: - Тест-кассета - 25 шт.; - Буферный раствор, 1,0 мл - 25 пр.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020: зонд пластиковый (полипропилен), тампон хлопковый, длина: 150 мм (РУ № РЗН 2021/15079, производства ООО "МиниМед", Россия) - 25 шт.; - Инструкция по применению - 1 шт. Комплект поставки: 1. Экспресс-тест для качественного иммунохроматографического определения антигенов респираторно-синцитиального вируса и/или гриппа А и В в респираторных выделениях «RSV/ГРИПП А+В-ИМБИАН-ИХА» по ТУ 21.20.23-072-39271034-2023. 2. Паспорт - 1 шт. (предоставляется в составе поставки на каждую серию изделий).

Roszdravnadzor Registration Number: РЗН 2024/22145

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Device Information

Device Name (English)

Device Name (Russian)

Device Type (English)

N/A

Device Type (Russian)

367660

Risk Class

Class 2b

OKPD Code

21.20.23.110

Registration Information

Registry Key

75119.0

Registration Number

РЗН 2024/22145

Registration Date

March 04, 2024

Manufacturer Information

Manufacturer Name (English)

IMBIAN LLC

Manufacturer Name (Russian)

ООО "ИМБИАН"

Country (English)

Russia

Country (Russian)

Россия

Legal Address (English)

ООО "ИМБИАН", Россия, 630554, Новосибирская область, р-н Новосибирский, МО Барышевский сельсовет, с. Барышево, ул. Ленина, д. 247, к. 4, 1 эт., помещ. №1, №2, №3, №4, №5, №6, №7, №8, №9, №10, №11, №12, №13, №14, №15, №24, №25, №26, №27, №30, №33, №34, №35, №36 - расположенные на 1-ом эт. зд. и №1, №2, №3, №4, №5, №6, №7, №8, №9, №10 - расположенные на 2-ом эт. зд.

Legal Address (Russian)

Manufacturing Address

630554, Россия, Новосибирская область, с.п. Барышевский сельсовет, м. р-н Новосибирский, с. Барышево, ул. Ленина, зд. 247, к. 4, помещ. 1