Panels › Microbiology › Product code NIJ · Class 2
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Regulation 866.1640
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 2 | 0 |
| Bd Diagnostics Science | 1 | 0 |
| Geneohm Sciences Canada, Inc. | 1 | 0 |
| Id Biomedical Corp. | 1 | 0 |
| Intelligent Medical Devices, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2024 | K243405 | Xpert vanA Cepheid® | NIJ |
| Jul 17, 2013 | K123753 | IMDX VANR FOR ABBOTT M2000 Intelligent Medical Devices, Inc. | NIJ |
| Oct 20, 2011 | K102416 | BD GENEOHM VANR ASSAY Bd Diagnostics Science | NIJ |
| Dec 17, 2009 | K092953 | Xpert VanA Assay Cepheid | NIJ |
| Aug 30, 2006 | K061686 | IDI-VANR ASSAY Geneohm Sciences Canada, Inc. | NIJ |
| May 1, 2002 | K020576 | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE Id Biomedical Corp. | NIJ |
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