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Device | VIDAS 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 |
Date Received | 02/17/2004 |
Decision Date | 07/08/2004 |
Withdrawal Date
|
10/11/2017 |
Product Code |
MTF |
Docket Number | 04M-0342 |
Notice Date | 08/04/2004 |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VIDAS TPSA ASSAY INDICATED AS FOLLOWS: VIDAS TPSA IS INTENDED FOR USE WITH A VIDAS (VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM) INSTRUMENT AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGE 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S011 S012 S013
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