Rapid test for semi-quantitative immunochromatographic determination of C-reactive protein concentration in serum, plasma and whole blood "CRB-IMBIAN-IHA" according to TU 21.20.23-038-41390295-2021 Composed of: Kit No 1 (in a package) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 pc.; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 1 pc.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 1 pc.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Kit No 2 (in the show box) is designed for the examination of 10 samples: - Test cassette - 10 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 10 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 10 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 10 pcs.; - Instructions for use - 1 pc. Kit No 3 (in a package) is designed for the examination of 20 samples: - Test strip - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Kit No 4 (in the show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 20 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 20 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 20 pcs.; - Instructions for use - 1 pc. Kit No 5 (in a package) 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 6 (in the show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 25 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 25 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 25 pcs.; - Instructions for use - 1 pc. Kit No 7 (in a package) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - Buffer solution, 3.0 ml - 2 bottles; - Instructions for use - 1 pc. Kit No 8 (in the package) is designed for the examination of 100 samples: - Test strip - 100 pcs. (in a tube); - Buffer solution, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Kit No 9 (in a show box or in a bag) is designed for the examination of 100 samples: - T est strip - 100 pcs.; - Buffer solution, 10.0 ml - 1 bottle; - 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. - Roszdravnadzor Registration РЗН 2022/19180
Access comprehensive regulatory information for Rapid test for semi-quantitative immunochromatographic determination of C-reactive protein concentration in serum, plasma and whole blood "CRB-IMBIAN-IHA" according to TU 21.20.23-038-41390295-2021 Composed of: Kit No 1 (in a package) is designed for the examination of 1 sample: - Test cassette - 1 pc.; - Buffer solution, 1.0 ml - 1 pc.; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 1 pc.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 1 pc.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 1 pc.; - Instructions for use - 1 pc. Kit No 2 (in the show box) is designed for the examination of 10 samples: - Test cassette - 10 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 10 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 10 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 10 pcs.; - Instructions for use - 1 pc. Kit No 3 (in a package) is designed for the examination of 20 samples: - Test strip - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Instructions for use - 1 pc. Kit No 4 (in the show box) is designed for the examination of 20 samples: - Test cassette - 20 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 20 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 20 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 20 pcs.; - Instructions for use - 1 pc. Kit No 5 (in a package) 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 6 (in the show box) is designed for the examination of 25 samples: - Test cassette - 25 pcs.; - Buffer solution, 3.0 ml - 1 bottle; - Medical piercing instruments: 3. Lancet (RU No FSZ 2011/09783) - 25 pcs.; - Injectable disposable alcohol wipe Inekta: design options: 2. 65x56 (RU No RZN 2013/822) - 25 pcs.; - MiniMed polymer pipettes as per TU 32.50.50-028-29508133-2019: 1. Pipettes for transferring liquids (Pasteur): 0.25 ml (RU No RZN 2019/8912) - 25 pcs.; - Instructions for use - 1 pc. Kit No 7 (in a package) is designed for the examination of 50 samples: - Test strip - 50 pcs. (in a tube); - Buffer solution, 3.0 ml - 2 bottles; - Instructions for use - 1 pc. Kit No 8 (in the package) is designed for the examination of 100 samples: - Test strip - 100 pcs. (in a tube); - Buffer solution, 10.0 ml - 1 bottle; - Instructions for use - 1 pc. Kit No 9 (in a show box or in a bag) is designed for the examination of 100 samples: - T est strip - 100 pcs.; - Buffer solution, 10.0 ml - 1 bottle; - 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 2022/19180 and manufactured by IMBIAN LAB LLC. The device was registered on July 24, 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.

