PMA P940034S003
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S003
- Product code
- MWA
- Decision date
- 1996-08-22
- 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 FOR THE MTD KIT TO INCLUDE AN ADDITIONAL WARNING AND AN EXPANDED LIMITATION REGARDIGN LOW POSITIVE RESULTS WITH MOTT.
Current openFDA PMA Record#
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S003
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 1996-08-22
- Decision code
- APPR
- Date received
- 1996-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGING THE PACKAGE INSERT FOR THE MTD KIT TO INCLUDE AN ADDITIONAL WARNING AND AN EXPANDED LIMITATION REGARDIGN LOW POSITIVE RESULTS WITH MOTT.