|
Device | GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P940034 |
Supplement Number | S010 |
Date Received | 05/12/1999 |
Decision Date | 05/25/1999 |
Reclassified Date
|
06/23/2014 |
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 30-day Notice for the following changes: revised performance specifications for specific materials and the addition of qualified vendors; and implementation of additional in-process qualification procedures for testing oligonucleo tide materials. |