Panels › Microbiology › Product code PEU · Class 2
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Regulation 866.3373
0510(k)s in 12 months (2 all time)
1recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PEU
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | Cepheid Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Open, Classified |
PEU | K143302 |
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