PMA P940034S007

Device: GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S007
Decision date: 1999-09-02
Approval order statement: Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.

Current openFDA PMA Record#

Device: GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S007
Decision date: 1999-09-02
Decision code: APPR
Date received: 1998-08-17
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.