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 (MTB) 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 | S010 |
Date Received | 11/05/2008 |
Decision Date | 11/25/2008 |
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 REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI). |
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