PMA P940040

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S001
Product code: MWA
Decision date: 2008-11-25
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Approval order statement: REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).

Current openFDA PMA Record

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S010
Product code: MWA
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Decision date: 2008-11-25
Decision code: OK30
Date received: 2008-11-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).