GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST
FDA premarket approval P940034/S008 · decided 1999-09-30
Approval details
- PMA number
- P940034
- Supplement
- S008
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST
- Applicant
- Gen-Probe, Inc.
- Date received
- 1998-09-04
- Decision date
- 1999-09-30
- Days to decision
- 391 days
- Decision code
- APPR
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- This device, a target-amplified nucleic acid probe test, is indicated for: the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA in acid-fast bacilli (AFB) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e.g., bronchalveolar lavages or bronchial aspirates) or tracheal aspirates. The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonar
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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 |