System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Code: 3510
Product Code(s):
NIJ 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
Device Classification Information
| Device Type ID | 3510 |
| Device Name | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NIJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3510 |
| Device | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Product Code | NIJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
TPLC Last Update: 2019-04-02 20:31:26