510(k) K143302 ยท PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 12, 2015 |
| Received | Nov 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | Cepheid Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Open, Classified |
PEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.