510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN200031Unknown

BioFire Respiratory Panel 2.1 (RP2.1)

BioFire Diagnostics, LLC, Salt Lake City UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN200031 is the FDA 510(k) clearance record for BioFire Respiratory Panel 2.1 (RP2.1), a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents). FDA's definition for product code QOF reads: "A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device...". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show no recalls naming DEN200031.

Clearance record

Decision date
Received
(302 days to decision)
Product code
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Regulation
21 CFR 866.3981
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, LLC 515 Colorow Dr., Salt Lake City UT
Third party review
No

Clearances, product code QOF

Trailing 12 months
7 clearances under product code QOF in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code QOF, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20263
October 20260