NIJ · System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | NIJ |
|---|---|
| Device Name | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243405 | Xpert vanA | Cepheid® | Nov 21, 2024 | SESE |
| K123753 | IMDX VANR FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | Jul 17, 2013 | SESE |
| K102416 | BD GENEOHM VANR ASSAY | Bd Diagnostics Science | Oct 20, 2011 | SESE |
| K092953 | Xpert VanA Assay | Cepheid | Dec 17, 2009 | SESE |
| K061686 | IDI-VANR ASSAY | Geneohm Sciences Canada, Inc. | Aug 30, 2006 | SESE |
| K020576 | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE | Id Biomedical Corp. | May 1, 2002 | SESE |
Top Applicants
- Bd Diagnostics Science — 1 clearance
- Cepheid — 1 clearance
- Cepheid® — 1 clearance
- Geneohm Sciences Canada, Inc. — 1 clearance
- Id Biomedical Corp. — 1 clearance
