PMA P940040S003

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S003
Product code: MWA
Decision date: 2004-04-22
Classification: Microbiology
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION.

Current openFDA PMA Record#

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S003
Product code: MWA
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Decision date: 2004-04-22
Decision code: OK30
Date received: 2004-04-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION.