|Device||GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST|
|10210 genetic center dr.|
|san diego, CA 92121|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| 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.