4 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Multichem ID-B Positive Control
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem ID-B Positive Control Mini-Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
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