PMA P940040S008

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S008
Product code: MWA
Decision date: 2008-01-11
Classification: Microbiology
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.

Current openFDA PMA Record#

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S008
Product code: MWA
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Decision date: 2008-01-11
Decision code: APPR
Date received: 2007-05-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.