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FDA 510(k)

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

K-Number: K243759 · 2024-12-20

ApplicantBiofire Diagnostics, LLC
Decision Date2024-12-20
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2024-12-20 under approval number K243759. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))?

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K243759.

When was BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) approved by the FDA?

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) received FDA 510(k) clearance on 2024-12-20, under approval number K243759.

What company makes BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))?

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))?

The FDA product code for BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) is PEN.

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Other Devices by Biofire Diagnostics, LLC

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Related Devices (Code: PEN)

K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc. K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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