PMA P040008S011

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S011
Product code: MTF
Decision date: 2015-04-22
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: CHANGE TO REMOVE EXTRANEOUS IN-PROCESS STABILITY TESTS PERFORMED ON THE STRIPS (STR) AND ON THE SOLID PHASE RECEPTACLES (SPR) OF THE KIT, AND CONSEQUENTLY TO ADD AN INSTRUCTION FOR THE STORAGE OF THE STR DURING THE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: VIDAS TOTAL PSA
Applicant: bioMerieux, Inc.
PMA number: P040008
Supplement: S011
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2015-04-22
Decision code: OK30
Date received: 2015-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO REMOVE EXTRANEOUS IN-PROCESS STABILITY TESTS PERFORMED ON THE STRIPS (STR) AND ON THE SOLID PHASE RECEPTACLES (SPR) OF THE KIT, AND CONSEQUENTLY TO ADD AN INSTRUCTION FOR THE STORAGE OF THE STR DURING THE MANUFACTURING PROCESS.