OEH · Class II · 21 CFR 866.3280

FDA Product Code OEH: Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit

To Aid In The Diagnosis Of Individuals Presenting With Signs And Symptoms Of Pneumonic Or Typhoidal Tularemia With A Qualitative In Vitro Diagnostic (ivd) Detection Of Target Dna Sequences Of Francisella Tularensis.

Leading manufacturers include Idaho Technology, Inc. and Biofire Diagnostics, Inc..

2
Total
2
Cleared
67d
Avg days
2007
Since

FDA 510(k) Cleared Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit Devices (Product Code OEH)

2 devices
1–2 of 2
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936
Biofire Diagnostics, Inc.
Microbiology · 34d
Cleared Dec 19, 2007
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
K072547
Idaho Technology, Inc.
Microbiology · 100d

About Product Code OEH - Regulatory Context