NIJ
6 FDA 510(k) clearances · Product code
84 daysmedian time to decision
422 days90th percentile
6clearances measured
FDA profile
- Official device name
- System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- FDA definition
- The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology
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| Record | Firm | Date |
|---|---|---|
| Xpert vanA (K243405) | Cepheid® | 2024-11-21 |
| IMDX VANR FOR ABBOTT M2000 (K123753) | Intelligent Medical Devices, Inc. | 2013-07-17 |
| BD GENEOHM VANR ASSAY (K102416) | Bd Diagnostics Science | 2011-10-20 |
| Xpert VanA Assay (K092953) | Cepheid | 2009-12-17 |
| IDI-VANR ASSAY (K061686) | Geneohm Sciences Canada, Inc. | 2006-08-30 |
| VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (K020576) | Id Biomedical Corp. | 2002-05-01 |
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