Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
FDA 510(k) clearance K143302 · decided 2015-02-12
Clearance details
- K-number
- K143302
- Device name
- Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2014-11-17
- Decision date
- 2015-02-12
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PEU
- Device class
- 2
- Regulation number
- 866.3373
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XPERT MTB/RIF ASSAY (DEN130032) | Cepheid | 2013-07-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. recall (Z-0724-2026) | Cepheid | 2025-11-26 |