Rapid test for qualitative immunochromatographic determination of influenza virus type A and B antigens in the biological material "Influenza A/B-IMBIAN-IHA" according to TU 21.20.23-114-41390295-2021 Composed of: Set Же 1 (in an individual cardboard box) is designed for research 1 sample (for differentiation of influenza virus type A and B antigens): - Test cassette - 1 pc.; - Buffer solution, 0.5 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. Set Же 2 (in an individual cardboard box) is designed for examination 1 sample (for differentiation of influenza virus type A, B and H1N1 virus antigens influenza A): - T eat-cassette - 1 pc.; - Buffer solution, 0.5 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. The Zhia 3 set {in a cardboard show box) is designed for the examination of 10 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 10 pcs.; - Buffer solution, 0.5 ml - 10 bottles; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 10 pcs.; - Instructions for use - 1 pc. The ZhA4 set (in a cardboard show box) is designed for the examination of 20 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 20 pcs.; - Buffer solution, 0.5 ml - 20 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Instructions for use - 1 pc. The Zhia 5 kit (in a zip-lock bag) is designed for the examination of 20 samples (to differentiate antigens of influenza virus types A, B and subtype H1N1 of influenza A virus): - A/B test strip - 20 pcs.; - Test strip H 1N 1 - 20 pcs.; - Buffer solution, 12.0 ml - 1 bottle; - Test tube - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Set No 6 {in a cardboard show box) is designed for the examination of 25 samples, including control samples, (to differentiate influenza virus type A and B antigens): - Test cassette - 25 pcs.; - Buffer solution, 0.5 ml - 25 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Ka(+) is a positive control sample containing recombinant influenza A virus antigens - 1 vial; - Kv(+) - a positive control sample containing a recombinant antigen influenza B virus - 1 vial; - K(-) - negative control sample - 1 fl.; - Instructions for use - 1 pc. Set L" 7 (in a cardboard show box) is designed for the examination of 25 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - A/B test strip - 25 pcs.; - Test strip H1N1 - 25 pcs.; - Buffer solution, 15.0 ml - 1 bottle; - Test tube - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. The La 8 kit (in a zip-lock bag) is designed for the examination of 25 samples (to differentiate antigens of influenza virus types A, B and subtype H1N1 of influenza A virus): - A/B test strip - 25 pcs.; - Test strip H1N1 - 25 pcs.; - Buffer solution, 0.5 ml - 25 capsules; - Test tube - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. The L"9 set (in a cardboard show box) is designed for the examination of 25 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - Test cassette - 25 pcs.; - Buffer solution, 15.0 ml - 1 bottle; - Test tube - 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.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Set No 10 (in a cardboard show box) is designed for the examination of 100 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 100 pcs.; - Buffer solution, 0.5 ml - 100 bottles; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 100 pcs.; - Instructions for use - 1 pc. Set M 11 (in a cardboard show box) is designed for the study of 100 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - A/B test strip - 100 pcs. (in a tube); - Test strip H1N1 - 100 pcs. (in a tube); - Buffer solution, 60.0 ml - 1 bottle; - Test tube - 100 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 100 pcs.; - Lodgment - 4 pcs.; - Instructions for use - 1 pc. The M 12 set (in a cardboard show box) is designed for the examination of 20 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 20 pcs.; - Buffer solution, 4.0 ml - 3 vials; - Dropper tube - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Package Included: - Rapid test "Influenza A/B-IMBIAN-IHA -Passport. - Roszdravnadzor Registration РЗН 2023/20730
Access comprehensive regulatory information for Rapid test for qualitative immunochromatographic determination of influenza virus type A and B antigens in the biological material "Influenza A/B-IMBIAN-IHA" according to TU 21.20.23-114-41390295-2021 Composed of: Set Же 1 (in an individual cardboard box) is designed for research 1 sample (for differentiation of influenza virus type A and B antigens): - Test cassette - 1 pc.; - Buffer solution, 0.5 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. Set Же 2 (in an individual cardboard box) is designed for examination 1 sample (for differentiation of influenza virus type A, B and H1N1 virus antigens influenza A): - T eat-cassette - 1 pc.; - Buffer solution, 0.5 ml - 1 bottle; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 1 pc.; - Instructions for use - 1 pc. The Zhia 3 set {in a cardboard show box) is designed for the examination of 10 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 10 pcs.; - Buffer solution, 0.5 ml - 10 bottles; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 10 pcs.; - Instructions for use - 1 pc. The ZhA4 set (in a cardboard show box) is designed for the examination of 20 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 20 pcs.; - Buffer solution, 0.5 ml - 20 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Instructions for use - 1 pc. The Zhia 5 kit (in a zip-lock bag) is designed for the examination of 20 samples (to differentiate antigens of influenza virus types A, B and subtype H1N1 of influenza A virus): - A/B test strip - 20 pcs.; - Test strip H 1N 1 - 20 pcs.; - Buffer solution, 12.0 ml - 1 bottle; - Test tube - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Set No 6 {in a cardboard show box) is designed for the examination of 25 samples, including control samples, (to differentiate influenza virus type A and B antigens): - Test cassette - 25 pcs.; - Buffer solution, 0.5 ml - 25 vials; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Ka(+) is a positive control sample containing recombinant influenza A virus antigens - 1 vial; - Kv(+) - a positive control sample containing a recombinant antigen influenza B virus - 1 vial; - K(-) - negative control sample - 1 fl.; - Instructions for use - 1 pc. Set L" 7 (in a cardboard show box) is designed for the examination of 25 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - A/B test strip - 25 pcs.; - Test strip H1N1 - 25 pcs.; - Buffer solution, 15.0 ml - 1 bottle; - Test tube - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. The La 8 kit (in a zip-lock bag) is designed for the examination of 25 samples (to differentiate antigens of influenza virus types A, B and subtype H1N1 of influenza A virus): - A/B test strip - 25 pcs.; - Test strip H1N1 - 25 pcs.; - Buffer solution, 0.5 ml - 25 capsules; - Test tube - 25 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. The L"9 set (in a cardboard show box) is designed for the examination of 25 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - Test cassette - 25 pcs.; - Buffer solution, 15.0 ml - 1 bottle; - Test tube - 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.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 25 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Set No 10 (in a cardboard show box) is designed for the examination of 100 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 100 pcs.; - Buffer solution, 0.5 ml - 100 bottles; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 100 pcs.; - Instructions for use - 1 pc. Set M 11 (in a cardboard show box) is designed for the study of 100 samples (for differentiation of influenza virus type A, B antigens and influenza A virus H1N1 subtype): - A/B test strip - 100 pcs. (in a tube); - Test strip H1N1 - 100 pcs. (in a tube); - Buffer solution, 60.0 ml - 1 bottle; - Test tube - 100 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 100 pcs.; - Lodgment - 4 pcs.; - Instructions for use - 1 pc. The M 12 set (in a cardboard show box) is designed for the examination of 20 samples (for differentiation of influenza virus antigens of types A and B): - Test cassette - 20 pcs.; - Buffer solution, 4.0 ml - 3 vials; - Dropper tube - 20 pcs.; - MiniMed sterile swab probe TU 32.50.50-034-29508133-2020, consisting of: 1. MiniMed sterile swab probe, design options: - plastic probe (polypropylene), cotton swab, length: 150 mm (RU No RZN 2021/15079) - 20 pcs.; - Lodgment - 1 pc.; - Instructions for use - 1 pc. Package Included: - Rapid test "Influenza A/B-IMBIAN-IHA -Passport. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2023/20730 and manufactured by IMBIAN LAB LLC. The device was registered on July 25, 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.

