FDA-Device2014-08-13Class II
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
BioMerieux SA
Hazard
Product is not approved or authorized for distribution in the US.
Sold states
FL, LA, MI, MS, NV, OH, OK, TN, TX
Affected count
1902
Manufactured in
Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, France
Products
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2152-2014Don't want to check this manually?
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