Yersinia Spp. Reagents
The Yersinia spp. Reagents are serological and nucleic acid amplification diagnostic reagents used to differentiate Yersinia species and presumptively identify Yersinia pestis from cultured isolates or clinical specimens, indicated as an aid in the laboratory diagnosis of plague. This device is classified as FDA Unclassified (class U) with an unclassified reason indicating it is pending classification, reviewed by the Microbiology panel; no regulation number has been assigned. The product code is OIH. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OIH
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131729 | JBAIDS PLAGUE DETECTION KIT | Jul 31, 2013 | Substantially Equivalent | Biofire Diagnostics, Inc. |