Device Recall LIFECODES PF4 Enhanced assay

Model / Serial
Kit Lot Number 3000389
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Product Description
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 || GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Manufacturer
Genetic Testing Institute,inc
1 Event
- Recall of Device Recall LIFECODES PF4 Enhanced assay

Manufacturer

Genetic Testing Institute,inc

Manufacturer Address
Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
Source
USFDA

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