PMA P940034S009

Device: AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S009
Decision date: 1998-12-01
Approval order statement: Approval for additional text under Warnings: "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PAC(TM) XPR-plus(TM) A.F.B. Processing Buffer have been shown to interfere with amplification."

Current openFDA PMA Record#

Device: AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S009
Decision date: 1998-12-01
Decision code: APPR
Date received: 1998-10-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for additional text under Warnings: "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PAC(TM) XPR-plus(TM) A.F.B. Processing Buffer have been shown to interfere with amplification."