Rapid test for qualitative immunochromatographic determination of SARS-CoV-2 coronavirus antigens and influenza A/B virus in the biological material "COVINFLUENZA-IMBIAN-IHA" according to TU 21.20.23-064-39271034-2023 Composed of: I. Rapid test "COVINFLUENZA-IMBIAN-IHA", consisting of: 1. Set No 1 (in a pack) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 2. Kit No 2 (in a package) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 3. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - test cassette - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 4. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - test strip - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 5. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - Instructions for use - 1 pc. 6. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 pr.; - MiniMed sterile swab probe TU 32.50,50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. II. Quality passport - 1 copy.
Russia·375010·IMBIAN LLC·Registered May 08, 2024·N/A- Device Name (English)
- Rapid test for qualitative immunochromatographic determination of SARS-CoV-2 coronavirus antigens and influenza A/B virus in the biological material "COVINFLUENZA-IMBIAN-IHA" according to TU 21.20.23-064-39271034-2023 Composed of: I. Rapid test "COVINFLUENZA-IMBIAN-IHA", consisting of: 1. Set No 1 (in a pack) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 2. Kit No 2 (in a package) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 3. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - test cassette - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 4. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - test strip - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 5. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - Instructions for use - 1 pc. 6. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 pr.; - MiniMed sterile swab probe TU 32.50,50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. II. Quality passport - 1 copy.
- Device Name (Russian)
- Экспресс-тест для качественного иммунохроматографического определения антигенов коронавируса SARS-CoV-2 и вируса гриппа A/B в биологическом материале "COVINFLUENZA-ИМБИАН-ИХА" по ТУ 21.20.23-064-39271034-2023 в составе: I. Экспресс-тест "COVINFLUENZA-ИМБИАН-ИХА", в составе: 1. Комплект № 1 (в пачке) рассчитан на исследование 1 образца: - тест-кассета - 1 шт.; - буферный раствор, 0,25 мл - 1 фл.; - тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 1 шт.; - инструкция по применению - 1 шт. 2. Комплект № 2 (в пакете) рассчитан на исследование 1 образца: - тест-кассета - 1 шт.; - буферный раствор, 0,25 мл - 1 фл.; - тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 1 шт.; - инструкция по применению - 1 шт. 3. Комплект № 3 (в картонном шоу-боксе) рассчитан на исследование 20 образцов: - тест-кассета - 20 шт.; - буферный раствор, 0,25 мл - 20 пр.; - тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 20 шт.; - ложемент - 1 шт.; - инструкция по применению - 1 шт. 4. Комплект № 4 (в картонном шоу-боксе) рассчитан на исследование 20 образцов: - тест-полоска - 20 шт.; - буферный раствор, 0,25 мл - 20 пр.; - тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 20 шт.; - ложемент - 1 шт.; - инструкция по применению - 1 шт. 5. Комплект № 5 (в картонном шоу-боксе) рассчитан на исследование 25 образцов: - тест-кассета - 25 шт.; - буферный раствор, 0,25 мл - 25 фл.; - тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 25 шт.; - инструкция по применению - 1 шт. 6. Комплект № 6 (в картонном шоу-боксе) рассчитан на исследование 25 образцов: - тест-кассета - 25 шт.; - буферный раствор, 0,25 мл - 25 пр.; - тампон-зонд МиниМед стерильный ТУ 32.50,50-034-29508133-2020, производства ООО "МиниМед", Россия, РУ № 2021/15079 - 25 шт.; - ложемент - 1 шт.; - инструкция по применению - 1 шт. II. Паспорт качества - 1 экз.
- Device Type (English)
- N/A
- Device Type (Russian)
- 375010
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 78200.0
- Registration Number
- РЗН 2024/22600
- Registration Date
- May 08, 2024
- 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)
- 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.
- Manufacturing Address
- 630554, Россия, Новосибирская область, м. р-н Новосибирский, с.п. Барышевский сельсовет, с. Барышево, ул. Ленина, зд. 247, к. 4, пом. 1
Access comprehensive regulatory information for Rapid test for qualitative immunochromatographic determination of SARS-CoV-2 coronavirus antigens and influenza A/B virus in the biological material "COVINFLUENZA-IMBIAN-IHA" according to TU 21.20.23-064-39271034-2023 Composed of: I. Rapid test "COVINFLUENZA-IMBIAN-IHA", consisting of: 1. Set No 1 (in a pack) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 2. Kit No 2 (in a package) is designed for the examination of 1 sample: - test cassette - 1 pc.; - buffer solution, 0.25 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 1 pc.; - Instructions for use - 1 pc. 3. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - test cassette - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 4. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - test strip - 20 pcs.; - buffer solution, 0.25 ml - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 20 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. 5. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - Instructions for use - 1 pc. 6. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - test cassette - 25 pcs.; - buffer solution, 0.25 ml - 25 pr.; - MiniMed sterile swab probe TU 32.50,50-034-29508133-2020, manufactured by MiniMed LLC, Russia, RU No 2021/15079 - 25 pcs.; - cradle - 1 pc.; - Instructions for use - 1 pc. II. Quality passport - 1 copy. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2024/22600 and manufactured by IMBIAN LLC. The device was registered on May 08, 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.