NIJClass II
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Microbiology · 21 CFR 866.1640
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
MDR events0All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances6All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Cepheid®Nov 21, 2024
K243405 · Xpert vanA
- Intelligent Medical Devices, Inc.Jul 17, 2013
K123753 · IMDX VANR FOR ABBOTT M2000
- Bd Diagnostics ScienceOct 20, 2011
K102416 · BD GENEOHM VANR ASSAY
- CepheidDec 17, 2009
K092953 · Xpert VanA Assay
- Geneohm Sciences Canada, Inc.Aug 30, 2006
K061686 · IDI-VANR ASSAY
- Id Biomedical Corp.May 1, 2002
K020576 · VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE