Cepheid · Class II · Cleared Oct 16, 2015
| K-number | K151565 |
| Device name | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit |
| Applicant | Cepheid |
| Product code | OUY |
| Device class | Class II |
| Decision date | Oct 16, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 866.3860 |
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