510(k) K131729
K131729 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, Inc. for the device "JBAIDS PLAGUE DETECTION KIT". The FDA issued a decision of Substantially Equivalent on July 31, 2013. The device falls under product code OIH (Yersinia Spp. Reagents), a Class U device. Biofire Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2013
- Date Received
- June 12, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Yersinia Spp. Reagents
- Device Class
- Class U
- Regulation Number
- Review Panel
- MI
- Submission Type
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.