Definition: Yersinia Spp. Reagents Are Devices That Consist Of Serological Reagents And Nucleic Acid Amplification Reagents To Differentiate Yersinia Spp. And Presumptively Identify Yersinia Pestis (Y. Pestis) From Cultured Isolates Or Clinical Specimens. They A
| Device Type ID | 3615 |
| Device Name | Yersinia Spp. Reagents |
| Physical State | Kit Includes Primers, Probes, Enzymes And Specific Controls For Amplification And Are Designed For Use With Specific Instrument Systems. |
| Technical Method | Nucleic Acid Amplification Reagents |
| Target Area | Systemic, Whole Blood, Sputum, |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OIH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |