Rapid test for qualitative immunochromatographic determination of troponin I in serum, plasma and whole blood "Troponin I-IMBIAN-IHA" according to TU 21.20.23-039-41390295-2021 Composed of: Set No 1 (in an individual cardboard box) is designed for examination 1 sample: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 1 pc.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a cardboard show box) is designed for the examination of 10 samples: - Test cassette - 10 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - Test strip - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 7 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 0.5 ml - 25 capsules; - Lancet (RU No FSZ 2011/09783) - 25 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 25 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 25 pcs.; - Instructions for use - 1 pc. Set No 8 (in a cardboard show box) is designed for the examination of 50 samples: - Test cassette - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 9 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 10 (in a cardboard show box) is designed for the examination of 100 samples; - Test cassette - 100 pcs.; - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 11 (in a cardboard show box) is designed for the examination of 100 samples: - Test floor - 100 pcs. (in a tube); - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 12 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 20 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 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·244790·IMBIAN LAB LLC·Registered May 20, 2024·Class 2a- Device Name (English)
- Rapid test for qualitative immunochromatographic determination of troponin I in serum, plasma and whole blood "Troponin I-IMBIAN-IHA" according to TU 21.20.23-039-41390295-2021 Composed of: Set No 1 (in an individual cardboard box) is designed for examination 1 sample: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 1 pc.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a cardboard show box) is designed for the examination of 10 samples: - Test cassette - 10 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - Test strip - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 7 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 0.5 ml - 25 capsules; - Lancet (RU No FSZ 2011/09783) - 25 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 25 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 25 pcs.; - Instructions for use - 1 pc. Set No 8 (in a cardboard show box) is designed for the examination of 50 samples: - Test cassette - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 9 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 10 (in a cardboard show box) is designed for the examination of 100 samples; - Test cassette - 100 pcs.; - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 11 (in a cardboard show box) is designed for the examination of 100 samples: - Test floor - 100 pcs. (in a tube); - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 12 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 20 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 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 тропонина I в сыворотке, плазме и цельной крови "Тропонин I-ИМБИАН-ИХА" по ТУ 21.20.23-039-41390295-2021 в составе: Комплект № 1 (в индивидуальной картонной пачке) рассчитан на исследование 1 образца: - Тест-кассета - 1 шт.; - Буферный раствор, 1,0 мл - 1 фл.; - Ланцет (РУ № ФСЗ 2011/09783) - 1 шт.; - Салфетка инъекционная спиртовая одноразовая Inekta (РУ № РЗН 2013/822) - 1 шт.; - Пипетка Пастера (РУ № РЗН 2019/8912) - 1 шт.; - Инструкция по применению - 1 шт. Комплект № 2 (в картонном шоу-боксе) рассчитан на исследование 10 образцов: - Тест-кассета - 10 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 3 (в картонном шоу-боксе) рассчитан на исследование 20 образцов: - Тест-кассета - 20 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 4 (в картонном шоу-боксе) рассчитан на исследование 20 образцов: - Тест-полоска - 20 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 5 (в картонном шоу-боксе) рассчитан на исследование 25 образцов: - Тест-кассета - 25 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 6 (в картонном шоу-боксе) рассчитан на исследование 25 образцов: - Тест-полоска - 25 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 7 (в картонном шоу-боксе) рассчитан на исследование 25 образцов: - Тест-кассета - 25 шт.; - Буферный раствор, 0,5 мл - 25 капсул; - Ланцет (РУ № ФСЗ 2011/09783) - 25 шт.; - Салфетка инъекционная спиртовая одноразовая Inekta (РУ № РЗН 2013/822) - 25 шт.; - Пипетка Пастера (РУ № РЗН 2019/8912) - 25 шт.; - Инструкция по применению - 1 шт. Комплект № 8 (в картонном шоу-боксе) рассчитан на исследование 50 образцов: - Тест-кассета - 50 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 9 (в картонном шоу-боксе) рассчитан на исследование 50 образцов: - Тест-полоска - 50 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 10 (в картонном шоу-боксе) рассчитан на исследование 100 образцов; - Тест-кассета - 100 шт.; - Буферный раcтвор, 10,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 11 (в картонном шоу-боксе) рассчитан на исследование 100 образцов: - Тест-полоcка - 100 шт. (в тубе); - Буферный раcтвор, 10,0 мл - 1 фл.; - Инструкция по применению - 1 шт. Комплект № 12 (в картонном шоу-боксе) рассчитан на исследование 20 образцов: - Тест-кассета - 20 шт.; - Буферный раствор, 3,0 мл - 1 фл.; - Ланцет (РУ № ФСЗ 2011/09783) - 20 шт.; - Салфетка инъекционная спиртовая одноразовая Inekta (РУ № РЗН 2013/822) - 20 шт.; - Пипетка Пастера (РУ № РЗН 2019/8912) - 20 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)
- 244790
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78570.0
- Registration Number
- РЗН 2022/18958
- Registration Date
- May 20, 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 troponin I in serum, plasma and whole blood "Troponin I-IMBIAN-IHA" according to TU 21.20.23-039-41390295-2021 Composed of: Set No 1 (in an individual cardboard box) is designed for examination 1 sample: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 1 pc.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 1 pc.; - Pasteur pipette (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Set No 2 (in a cardboard show box) is designed for the examination of 10 samples: - Test cassette - 10 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 3 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 4 (in a cardboard show box) is designed for the examination of 20 samples: - Test strip - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 5 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 6 (in a cardboard show box) is designed for the examination of 25 samples: - Test strip - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 7 (in a cardboard show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 0.5 ml - 25 capsules; - Lancet (RU No FSZ 2011/09783) - 25 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 25 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 25 pcs.; - Instructions for use - 1 pc. Set No 8 (in a cardboard show box) is designed for the examination of 50 samples: - Test cassette - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 9 (in a cardboard show box) is designed for the examination of 50 samples: - Test strip - 50 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 10 (in a cardboard show box) is designed for the examination of 100 samples; - Test cassette - 100 pcs.; - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 11 (in a cardboard show box) is designed for the examination of 100 samples: - Test floor - 100 pcs. (in a tube); - Buffer spread, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Set No 12 (in a cardboard show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Lancet (RU No FSZ 2011/09783) - 20 pcs.; - Disposable injection alcohol napkin Inekta (RU No RZN 2013/822) - 20 pcs.; - Pasteur pipette (RU No RZN 2019/8912) - 20 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 2022/18958 and manufactured by IMBIAN LAB LLC. The device was registered on May 20, 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.