OIH — Yersinia Spp. Reagents Class U
FDA product code OIH covers "Yersinia Spp. Reagents", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OIH
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131729 | biofire diagnostics | JBAIDS PLAGUE DETECTION KIT | July 31, 2013 |