|
Device | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P940034 |
Supplement Number | S011 |
Date Received | 10/25/2000 |
Decision Date | 11/21/2000 |
Reclassified Date
|
06/23/2014 |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF THE ENZYME DILUTION BUFFER AND TENTATIE RECONSTITUTED STABILITY (PENDING COMPLETION OF REAL-TIME STUDIES) OF THE ENZYME REAGENT FOR 30 DAYS WITH AN ADDED PRECAUTION, AND OTHER MINOR CHANGES TO THE LABELING (INCLUDING CLARIFICATION OF CONTROL TESTING PROCEDURES). |