PMA P080008S001

Device: VIDAS FREE PSA (FPSA) ASSAY
Applicant: bioMerieux, Inc.
PMA number: P080008
Supplement: S001
Product code: MTG
Decision date: 2012-02-08
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.

Current openFDA PMA Record#

Device: VIDAS FREE PSA (FPSA) ASSAY
Applicant: bioMerieux, Inc.
PMA number: P080008
Supplement: S001
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2012-02-08
Decision code: OK30
Date received: 2012-01-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.