510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170017Unknown

FilmArray Respiratory Panel 2 plus (RP2plus)

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

DEN170017 is the FDA 510(k) clearance record for FilmArray Respiratory Panel 2 plus (RP2plus), a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code PZF (Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System). FDA's definition for product code PZF reads: "A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification of MERS-CoV and common...". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show no recalls naming DEN170017.

Clearance record

Decision date
Received
(253 days to decision)
Product code
PZF Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
Regulation
21 CFR 866.4001
Device class
Class II
Review panel
Pathology
Applicant
Biofire Diagnostics, LLC 515 Colorow Dr., Salt Lake City UT
Third party review
No

Clearances, product code PZF

Trailing 12 months

FDA records hold no clearances under product code PZF in the trailing twelve months.

FDA records show no clearances under product code PZF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260