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Devices
PLAC Test Reagent Kit, immunoturbidimetric method
Model / Serial
Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to 123 consignees throughout the US.
Product Description
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
Manufacturer
DiaDexus, Inc
6 Events
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
Recall of PLAC Test Reagent Kit, immunoturbidimetric method
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Manufacturer
DiaDexus, Inc
Manufacturer Address
DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
Manufacturer Parent Company (2017)
DiaDexus, Inc
Source
USFDA
Language
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