Product code OIH— Unknown

JBAIDS PLAGUE DETECTION KIT

Classification name: Yersinia Spp. Reagents
Device class: Unclassified
Advisory panel: Unknown
Total cleared: 1
First cleared: 2013-07-31
Most recent: 2013-07-31

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OIH, via openFDA

Market context for product code OIH

FDA has cleared 1 device under product code OIH, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code.

Top applicants under product code OIH

Biofire Diagnostics, Inc.1 clearance

Recent clearances under product code OIH

K131729 — JBAIDS PLAGUE DETECTION KITBiofire Diagnostics, Inc.·2013-07-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.