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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K071255
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ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. 2 08/22/2019 Aniara Diagnostica LLC
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. 2 08/22/2019 Aniara Diagnostica LLC
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for... 2 05/08/2018 Hyphen BioMed
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-depe... 2 05/08/2018 Hyphen BioMed
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended f... 2 05/08/2018 Hyphen BioMed
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of hepari... 2 03/15/2018 Hyphen BioMed
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection ... 2 03/15/2018 Hyphen BioMed
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