Rapid test for qualitative immunochromatographic determination of amniotic fluid leakage in rupture of membranes in vaginal secretions "AMNIO-IMBIAN-IHA" according to TU 21.20.23-090-41390295-2021 Composed of: I. Set No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. II. Kit No 2 (in a package) is designed for the examination of 1 sample: - Test strip - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. III. Kit No 3 (in the show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 0.3 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. IV. Kit No 4 (in show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. V. Set No 5 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. Each delivery must include a quality certificate in one copy, regardless of the number of rapid tests in the delivery.
Russia·157760·IMBIAN LAB LLC·Registered June 10, 2024·Class 2a- Device Name (English)
- Rapid test for qualitative immunochromatographic determination of amniotic fluid leakage in rupture of membranes in vaginal secretions "AMNIO-IMBIAN-IHA" according to TU 21.20.23-090-41390295-2021 Composed of: I. Set No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. II. Kit No 2 (in a package) is designed for the examination of 1 sample: - Test strip - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. III. Kit No 3 (in the show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 0.3 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. IV. Kit No 4 (in show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. V. Set No 5 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. Each delivery must include a quality certificate in one copy, regardless of the number of rapid tests in the delivery.
- Device Name (Russian)
- Экспресс-тест для качественного иммунохроматографического определения подтекания околоплодных вод при разрыве плодных оболочек во влагалищных выделениях "АМНИО-ИМБИАН-ИХА" по ТУ 21.20.23-090-41390295-2021 в составе: I. Комплект № 1 (в пачке) рассчитан на исследование 1 образца: - Тест-кассета - 1 шт.; - Буферный раствор, 0,3 мл - 1 шт.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020 (РУ № РЗН 2021/15079) - 1 шт.; - Инструкция по применению - 1 шт. II. Комплект № 2 (в пакете) рассчитан на исследование 1 образца: - Тест-полоска - 1 шт.; - Буферный раствор, 0,3 мл - 1 шт.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020 (РУ № РЗН 2021/15079) - 1 шт.; - Инструкция по применению - 1 шт. III. Комплект № 3 (в шоу-боксе) рассчитан на исследование 25 образцов: - Тест-полоска - 25 шт.; - Буферный раствор, 0,3 мл - 25 шт.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020 (РУ № РЗН 2021/15079) - 25 шт.; - Ложемент - 1 шт.; - Инструкция по применению - 1 шт. IV. Комплект № 4 (в шоу-боксе) рассчитан на исследование 50 образцов: - Тест-полоска - 50 шт.; - Буферный раствор, 0,3 мл - 50 шт.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020 (РУ № РЗН 2021/15079) - 50 шт.; - Ложемент - 2 шт.; - Инструкция по применению - 1 шт. V. Комплект № 5 (в картонном шоу-боксе) рассчитан на исследование 50 образцов: - Тест-полоска - 50 шт. (в тубе); - Буферный раствор, 0,3 мл - 50 шт.; - Тампон-зонд МиниМед стерильный ТУ 32.50.50-034-29508133-2020 (РУ № РЗН 2021/15079) - 50 шт.; - Ложемент - 2 шт.; - Инструкция по применению - 1 шт. В комплект каждой поставки должен входить паспорт качества в одном экземпляре независимо от количества экспресс-тестов в поставке.
- Device Type (English)
- N/A
- Device Type (Russian)
- 157760
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78207.0
- Registration Number
- РЗН 2022/18852
- Registration Date
- June 10, 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, Koltsovo, Novosibirsk Region, 630559, Russia. Koltsovo, Sadovaya st., 2/7
- Legal Address (Russian)
- ООО "ИМБИАН ЛАБ", Россия, 630559, Новосибирская область, р. п. Кольцово, г.о. рп. Кольцово, ул. Садовая, д 2/7
- 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 Rapid test for qualitative immunochromatographic determination of amniotic fluid leakage in rupture of membranes in vaginal secretions "AMNIO-IMBIAN-IHA" according to TU 21.20.23-090-41390295-2021 Composed of: I. Set No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. II. Kit No 2 (in a package) is designed for the examination of 1 sample: - Test strip - 1 pc.; - Buffer solution, 0.3 ml - 1 pc.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. III. Kit No 3 (in the show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 0.3 ml - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. IV. Kit No 4 (in show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. V. Set No 5 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - Buffer solution, 0.3 ml - 50 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020 (RU No RZN 2021/15079) - 50 pcs.; - Cradle - 2 pcs.; - Instructions for use - 1 pc. Each delivery must include a quality certificate in one copy, regardless of the number of rapid tests in the delivery. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2022/18852 and manufactured by IMBIAN LAB LLC. The device was registered on June 10, 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.