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. |
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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 | S006 |
Date Received | 11/17/2005 |
Decision Date | 12/14/2005 |
Withdrawal Date
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09/06/2013 |
Product Code |
MWA |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE PURIFICATION PROCESS. |
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