PMA P940034S001
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S001
- Product code
- MWA
- Decision date
- 1996-04-23
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- APPROVAL FOR: 1)A COMPONENT (NALC) IN A LIQUID REAGENT (ENZYME DILUTION BUFFER) IS MOVED TO A LYOPHILIZED REAGENT (ENZYME REAGENT), RESULTING IN A STABILITY SHELF LIFE OF 1 YEAR FOR THE REAGENTS AND 1 YEAR FOR THE KIT; 2) ADD AN ADDITIONAL VENDOR OF REVERSE TRANSCRIPTASE; AND, 3) INSIGNIFICANT CHANGES TO THE PACKAGE INSERT
Current openFDA PMA Record#
- Device
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S001
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 1996-04-23
- Decision code
- APPR
- Date received
- 1996-02-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1)A COMPONENT (NALC) IN A LIQUID REAGENT (ENZYME DILUTION BUFFER) IS MOVED TO A LYOPHILIZED REAGENT (ENZYME REAGENT), RESULTING IN A STABILITY SHELF LIFE OF 1 YEAR FOR THE REAGENTS AND 1 YEAR FOR THE KIT; 2) ADD AN ADDITIONAL VENDOR OF REVERSE TRANSCRIPTASE; AND, 3) INSIGNIFICANT CHANGES TO THE PACKAGE INSERT