PMA P940034S002
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S002
- Product code
- MWA
- Decision date
- 1996-06-05
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- APPROVAL FOR CHANGING THE PACKAGE INSERT TO INCLUDE MORE DETAILS ON ADEQUATE VORTEXING
Current openFDA PMA Record#
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S002
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 1996-06-05
- Decision code
- APPR
- Date received
- 1996-05-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGING THE PACKAGE INSERT TO INCLUDE MORE DETAILS ON ADEQUATE VORTEXING