Device product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Z-2152-2014
Product summary
- Firm
- BioMerieux SA
- Event
- Event 68749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1902
- Official record key
device-enforcement:Z-2152-2014
Official wording
Reason: Product is not approved or authorized for distribution in the US.
Code information: Lot 1001904130
Distribution pattern: FL, LA, MI, MS, NV, OH, OK, TN, TX
Derived failure modes
-
Unknown
Product is not approved or authorized for distribution in the US.