JBAIDS ANTHRAX DETECTION KIT

Assay, Nucleic Acid Amplification, Bacillus Anthracis

BIOFIRE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Jbaids Anthrax Detection Kit.

Pre-market Notification Details

Device IDK131930
510k NumberK131930
Device Name:JBAIDS ANTHRAX DETECTION KIT
ClassificationAssay, Nucleic Acid Amplification, Bacillus Anthracis
Applicant BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
ContactCynthia Phillips
CorrespondentCynthia Phillips
BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
Product CodeNHT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-27
Decision Date2013-08-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851458005037 K131930 000

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