GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
FDA premarket approval P940034/S001 · decided 1996-04-23
Approval details
- PMA number
- P940034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Gen-Probe, Inc.
- Date received
- 1996-02-23
- Decision date
- 1996-04-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062) | Gen-Probe, Inc. | 2013-01-09 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
| GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (K063664) | Gen-Probe, Inc. | 2007-01-25 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451) | Gen-Probe, Inc. | 2007-01-22 |
| GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (K062440) | Gen-Probe, Inc. | 2006-11-07 |
| APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413) | Gen-Probe, Inc. | 2006-10-13 |
| TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (K061509) | Gen-Probe, Inc. | 2006-10-04 |
| TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (K060652) | Gen-Probe, Inc. | 2006-08-17 |