PMA P940034S005
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S005
- Product code
- MWA
- Decision date
- 1998-01-07
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- Approval for Physician Prescribing Information to be considered a component of the labeling for MTD. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material.
Current openFDA PMA Record#
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S005
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 1998-01-07
- Decision code
- APPR
- Date received
- 1997-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Physician Prescribing Information to be considered a component of the labeling for MTD. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material.