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 | AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST |
Generic Name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
Regulation Number | 866.3372 |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P940034 |
Supplement Number | S019 |
Date Received | 11/07/2012 |
Decision Date | 12/05/2012 |
Reclassified Date
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06/23/2014 |
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 IN THE AMPLIFICATION POSITIVE CONTROL USED FOR QUALITY CONTROL TESTING. |
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