Devices

Device Recall ZYMUTEST HIA IgGAM ELISA

Model / Serial
Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
OH, MD, NC, NY, NH, Canada, Sweden
Product Description
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.
Manufacturer
Hyphen BioMed
1 Event
- Recall of Device Recall ZYMUTEST HIA IgGAM ELISA

Manufacturer

Hyphen BioMed

Manufacturer Address
Hyphen BioMed, 155 rue d Eragny, Neuville Sur Oise France
Manufacturer Parent Company (2017)
Hyphen Biomed
Source
USFDA

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