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FDA 510(k)

FilmArray Blood Culture Identification (BCID) Panel

K-Number: K181493 · 2018-07-05

ApplicantBiofire Diagnostics, LLC
Decision Date2018-07-05
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Blood Culture Identification (BCID) Panel 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 2018-07-05 under 510(k) number K181493. 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 FilmArray Blood Culture Identification (BCID) Panel?

FilmArray Blood Culture Identification (BCID) Panel is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K181493.

When did FilmArray Blood Culture Identification (BCID) Panel receive FDA 510(k) clearance?

FilmArray Blood Culture Identification (BCID) Panel received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181493.

Who is the listed applicant for FilmArray Blood Culture Identification (BCID) Panel?

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 FilmArray Blood Culture Identification (BCID) Panel?

The FDA product code for FilmArray Blood Culture Identification (BCID) Panel is PEN.

Other records listing Biofire Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

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Related Devices (Code: PEN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex CorporationK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLCK213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.K182619ePlex 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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