|
Device | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD 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 | S005 |
Date Received | 07/02/1997 |
Decision Date | 01/07/1998 |
Reclassified Date
|
06/23/2014 |
Product Code |
MWA |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Physician Prescribing Information to be considered a component of the labeling for MTD. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material. |