PMA P940034S011

Device: GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S011
Decision date: 2000-11-21
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).

Current openFDA PMA Record#

Device: GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S011
Decision date: 2000-11-21
Decision code: APPR
Date received: 2000-10-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).