|
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 | S001 |
Date Received | 09/04/2008 |
Decision Date | 09/25/2008 |
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 CHANGE OF VENDOR FOR THE MOUSE MONOCLONAL ANTIBODY USED IN THE MANUFACTURE OF THE DEVICE. |