OIH

FDA Product Code OIH: Yersinia Spp. Reagents

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.

Leading manufacturers include Biofire Diagnostics, Inc..

1
Total
1
Cleared
49d
Avg days
2013
Since

FDA 510(k) Cleared Yersinia Spp. Reagents Devices (Product Code OIH)

1 devices
1–1 of 1
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729
Biofire Diagnostics, Inc.
Microbiology · 49d

About Product Code OIH - Regulatory Context