FDA 510(k)

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

K-Nummer: K243759 · 2024-12-20

Entscheidungsdatum2024-12-20

ProduktcodePEN

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K243759.

When did BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) receive FDA 510(k) clearance?

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 510(k) number K243759.

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

The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Verwandte Geräte (Code: PEN)

K262168QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbH K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K193519BioFire Blood Culture Identification 2 (BCID2) 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

Offizielle Quelle

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