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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2015 | K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 Cepheid | PEU |
| Jul 25, 2013 | DEN130032 | XPERT MTB/RIF ASSAY Cepheid | PEU |
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