Devices

Device Recall ZYMUTEST HIA MonoStrip IgGAM

Model / Serial
UDI: 03663537046810. Lot Number: F1700416.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Product Description
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.
Manufacturer
Hyphen BioMed
1 Event
- Recall of Device Recall ZYMUTEST HIA MonoStrip IgGAM

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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