System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
FDA product code PEU · Class II (moderate risk) · 21 CFR 866.3373 · Microbiology
The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
1510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Cepheid 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s…PEU · Traditional | Cepheid | 02/12/2015SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0724-2026 Class II | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Product testing did not meet expected stability criteria. | Cepheid | 11/05/2025Open, Classified |