Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST |
Generic Name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
Regulation Number | 866.3372 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P940040 |
Supplement Number | S009 |
Date Received | 12/19/2007 |
Decision Date | 08/26/2008 |
Withdrawal Date
|
09/06/2013 |
Product Code |
MWA |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS. |
|
|