NIJ — System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Class II
Classification Details
- Product Code
- NIJ
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243405 | cepheid® | Xpert vanA | November 21, 2024 |
| K123753 | intelligent medical devices | IMDX VANR FOR ABBOTT M2000 | July 17, 2013 |
| K102416 | bd diagnostics science | BD GENEOHM VANR ASSAY | October 20, 2011 |
| K092953 | cepheid | Xpert VanA Assay | December 17, 2009 |
| K061686 | geneohm sciences canada | IDI-VANR ASSAY | August 30, 2006 |
| K020576 | id biomedical | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE | May 1, 2002 |