AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
FDA premarket approval P940040/S009 · decided 2008-08-26
Approval details
- PMA number
- P940040
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2007-12-19
- Decision date
- 2008-08-26
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.
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