Devices

Device Recall diaDexus PLAC Test Reagent Kit

Model / Serial
sub lot of lot 088061, expiration date 2008-12
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 || Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
Manufacturer
DiaDexus, Inc
1 Event
- Recall of Device Recall diaDexus PLAC Test Reagent Kit

Manufacturer

DiaDexus, Inc

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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