|
Device | VIDAS TOTAL PSA (TPSA) ASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
PMA Number | P040008 |
Supplement Number | S008 |
Date Received | 02/03/2014 |
Decision Date | 03/06/2014 |
Withdrawal Date
|
10/11/2017 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR THE CRITICAL COMPONENT: 4 AND 8 ML CAPACITY GLASS VIALS. |