Devices

Device Recall PLAC Test Reagent Kit

Model / Serial
All lot codes under recall.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US, OUS: UK and Germany.
Product Description
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Manufacturer
DiaDexus, Inc
1 Event
- Recall of Device Recall PLAC Test Reagent Kit

Manufacturer

DiaDexus, Inc

Manufacturer Address
DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080-1913
Manufacturer Parent Company (2017)
DiaDexus, Inc
Source
USFDA

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