PMA P940034S010

Device: GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S010
Decision date: 1999-05-25
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.

Current openFDA PMA Record#

Device: GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S010
Decision date: 1999-05-25
Decision code: OK30
Date received: 1999-05-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.