FDA-Device2016-09-14Class II
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Siemens Healthcare Diagnostics, Inc
Hazard
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Sold states
Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway Pakistan Poland Portugal Qatar Romania Russian Fed. Senegal Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey Unit.Arab Emir. Uzbekistan Vatican
Manufactured in
333 Coney St, East Walpole, MA, United States
Products
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2742-2016Don't want to check this manually?
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