PMA P940034S016
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S016
- Product code
- MWA
- Decision date
- 2004-10-08
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- ELIMINATION OF A SPECIFICATION FOR THE CONTROL REAGENTS THAT ARE NO LONGER INCLUDED AS PART OF THE MTD TEST KIT.
Current openFDA PMA Record#
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S016
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2004-10-08
- Decision code
- OK30
- Date received
- 2004-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF A SPECIFICATION FOR THE CONTROL REAGENTS THAT ARE NO LONGER INCLUDED AS PART OF THE MTD TEST KIT.