|
Device | ELECSYS TOTAL PSA IMMUNOASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Supplement Number | S002 |
Date Received | 01/23/2006 |
Decision Date | 04/12/2006 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL STEP INTO THE STANDARDIZATION INSTRUCTIONS FOR THE ELECSYS TOTAL PSA IMMUNOASSAY. |