PMA P040008S005

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S005
Product code: MTF
Decision date: 2013-03-08
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY.

Current openFDA PMA Record#

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S005
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2013-03-08
Decision code: OK30
Date received: 2013-02-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY.