OIH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Yersinia Spp. Reagents
- Device class
- Unclassified
- Medical specialty
- Unknown
- FDA 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 are indicated for use as an aid in the laboratory of diagnosis of plague.
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| Record | Firm | Date |
|---|---|---|
| JBAIDS PLAGUE DETECTION KIT (K131729) | Biofire Diagnostics, Inc. | 2013-07-31 |
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