PMA P940034S013
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S013
- Product code
- MWA
- Decision date
- 2002-01-25
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- APPROVAL FOR CHANGES TO THE RELATIVE LIGHT UNITS (RLU) SPECIFICATION FOR THE 0.2-0.3 MM WASHED GLASS BEADS (PART NO. 101321) AND FILLED LYSING TUBES (PART NO. 102606).
Current openFDA PMA Record#
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S013
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2002-01-25
- Decision code
- APPR
- Date received
- 2001-12-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE RELATIVE LIGHT UNITS (RLU) SPECIFICATION FOR THE 0.2-0.3 MM WASHED GLASS BEADS (PART NO. 101321) AND FILLED LYSING TUBES (PART NO. 102606).