7 results
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28ms
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Sources: EU EUDAMED, US FDA
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Country: France
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HYPHEN BioMed
Manufacturer
🇫🇷 France
HYPHEN BIOMED SASU
FDA registration
HYPHEN BIOMED SASU·10 products·🇫🇷 France
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
FDA Enforcement
Class II
·Terminated·Hyphen BioMed·May 16, 2018
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
FDA Enforcement
Class II
·Terminated·Hyphen BioMed·May 16, 2018
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
FDA Enforcement
Class II
·Terminated·Hyphen BioMed·March 21, 2018
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
FDA Enforcement
Class II
·Terminated·Hyphen BioMed·March 21, 2018
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Hyphen BioMed·May 16, 2018