Rapid test for qualitative immunochromatographic determination of follicle-stimulating hormone in urine "FSH-IMBIAN-IHA" according to TU 21.20.23-168-41390295-2022 Composed of: Kit No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a pack) is designed for the examination of 2 samples: - Test strip - 2 pcs.; - Instructions for use - 1 pc. Set No 3 (in the show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 pcs.; - Instructions for use - 1 pc. Kit No 4 (in the package) is designed for the examination of 25 samples: - Test strip - 25 pcs. (in a tube); - Instructions for use - 1 pc. Kit No 5 (in a package) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - 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·380380·IMBIAN LAB LLC·Registered June 19, 2024·Class 2a- Device Name (English)
- Rapid test for qualitative immunochromatographic determination of follicle-stimulating hormone in urine "FSH-IMBIAN-IHA" according to TU 21.20.23-168-41390295-2022 Composed of: Kit No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a pack) is designed for the examination of 2 samples: - Test strip - 2 pcs.; - Instructions for use - 1 pc. Set No 3 (in the show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 pcs.; - Instructions for use - 1 pc. Kit No 4 (in the package) is designed for the examination of 25 samples: - Test strip - 25 pcs. (in a tube); - Instructions for use - 1 pc. Kit No 5 (in a package) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - 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 фолликулостимулирующего гормона в моче "ФСГ-ИМБИАН-ИХА" по ТУ 21.20.23-168-41390295-2022 в составе: Комплект № 1 (в пачке) рассчитан на исследование 1 образца: - Тест-кассета - 1 шт.; - Пипетка Пастера (РУ № РЗН 2019/8912) - 1 шт.; - Инструкция по применению - 1 шт. Комплект № 2 (в пачке) рассчитан на исследование 2 образцов: - Тест-полоска - 2 шт.; - Инструкция по применению - 1 шт. Комплект № 3 (в шоу-боксе) рассчитан на исследование 20 образцов: - Тест-кассета - 20 шт.; - Пипетка Пастера (РУ № РЗН 2019/8912) - 20 шт.; - Инструкция по применению - 1 шт. Комплект № 4 (в пакете) рассчитан на исследование 25 образцов: - Тест-полоска - 25 шт. (в тубе); - Инструкция по применению - 1 шт. Комплект № 5 (в пакете) рассчитан на исследование 50 образцов: - Тест-полоска - 50 шт. (в тубе); - 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)
- 380380
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78203.0
- Registration Number
- РЗН 2023/19376
- Registration Date
- June 19, 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, 2/7 Sadovaya St., Koltsovo, Novosibirsk Region, 630559 Russia
- Legal Address (Russian)
- ООО "ИМБИАН ЛАБ", Россия, 630559, Новосибирская область, р. п. 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 follicle-stimulating hormone in urine "FSH-IMBIAN-IHA" according to TU 21.20.23-168-41390295-2022 Composed of: Kit No 1 (in a pack) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a pack) is designed for the examination of 2 samples: - Test strip - 2 pcs.; - Instructions for use - 1 pc. Set No 3 (in the show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 pcs.; - Instructions for use - 1 pc. Kit No 4 (in the package) is designed for the examination of 25 samples: - Test strip - 25 pcs. (in a tube); - Instructions for use - 1 pc. Kit No 5 (in a package) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - 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 2023/19376 and manufactured by IMBIAN LAB LLC. The device was registered on June 19, 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.