PMA P940040S009

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S009
Product code: MWA
Decision date: 2008-08-26
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., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.

Current openFDA PMA Record#

Device: AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P940040
Supplement: S009
Product code: MWA
Generic name: System, nucleic acid amplification, mycobacterium tuberculosis complex
Decision date: 2008-08-26
Decision code: APPR
Date received: 2007-12-19
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., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.