PMA P040008S006

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S006
Product code: MTF
Decision date: 2013-03-13
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: ADDITION OF AN ALTERNATE ALKALINE PHOSPHATASE (ALP) FROM THE SAME QUALIFIED SUPPLIER; IT ALSO PROPOSED AN IMPROVEMENT TO THE QUALITY CONTROLS PERFORMED ON THISMATERIAL.

Current openFDA PMA Record#

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S006
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2013-03-13
Decision code: OK30
Date received: 2013-02-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ALTERNATE ALKALINE PHOSPHATASE (ALP) FROM THE SAME QUALIFIED SUPPLIER; IT ALSO PROPOSED AN IMPROVEMENT TO THE QUALITY CONTROLS PERFORMED ON THISMATERIAL.