Devices

Device Recall ZYMUTEST HIA MonoStrip IgG ELISA

Model / Serial
Lot numbers: F1701084P2 and F1701084P3
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
OH, MD, NC, NY, NH, Canada, Sweden
Product Description
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.
Manufacturer
Hyphen BioMed
1 Event
- Recall of Device Recall ZYMUTEST HIA MonoStrip IgG 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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