International Medical Devices Database

Manufacturer Address
DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080-1913
Manufacturer Parent Company (2017)
DiaDexus, Inc
Source
USFDA
2 Events
- Recall of Device Recall PLAC Test ELISA Kit
- Recall of Device Recall PLAC Test Reagent Kit

2 devices in the database

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

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.

One manufacturer with a similar name

Learn more about the data here

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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Disclaimer

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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