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17ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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HBM Medical
Authorized representative
🇮🇪 Ireland·1 Manufacturer·23 Devices
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 28, 2022