OIHUnclassified

Yersinia Spp. Reagents

Unknown

OIH is the FDA product code for Yersinia Spp. Reagents. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2013-07-31, and no recalls.

Classification record

Product code: OIH
Device name: Yersinia Spp. Reagents
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.
Device class: Unclassified
Review panel: Unknown
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OIH

By decision year

1 clearance under product code OIH with a decision year between 2013 and 2013, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OIH by decision year
Year	Clearances
2013	1

Applicants with the most clearances

Product code OIH

Applicants holding the most 510(k) clearances under product code OIH
Applicant	Clearances
BioFire Diagnostics, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OIH.

Recent clearances

Product code OIH

K131729UnclassifiedJbaids Plague Detection KitBiofire Diagnostics, Inc. / cleared 2013-07-31

Recent recalls

Product code OIH

FDA records show no recalls under product code OIH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)