Devices

Device Recall PLAC Test ELISA Kit

Model / Serial
Lot Number: 907090; Part Number: 90123; Product Code NOE
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
Product Description
diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 || The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.
Manufacturer
DiaDexus, Inc
1 Event
- Recall of Device Recall PLAC Test ELISA 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

2 devices with a similar name

Learn more about the data here

Device Recall PLAC Test ELISA Kit

Model / Serial
All lots
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US, OUS: UK and Germany.
Product Description
PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
Manufacturer
DiaDexus, Inc

Device Recall PLAC Test ELISA Kit

Model / Serial
Lot number 910013, expiration date 05/31/2010
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
Product Description
diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
Manufacturer
DiaDexus, Inc

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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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