Biofire Diagnostics, LLC

FDA 510(k) & PMA Approved Dispositivos — 20 products

Total de dispositivos20

Categorías0

Última decisión de la FDA

Tipo	Número	Nombre del dispositivo	Código	Fecha	Acciones
510(k)	K243544	BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini	QOF	2025-08-14	Ver
510(k)	K243885	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid	PCH	2025-01-16	Ver
510(k)	K243759	BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))	PEN	2024-12-20	Ver
510(k)	K242367	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel	PCH	2024-11-07	Ver
510(k)	K241194	BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini	QOF	2024-05-30	Ver
510(k)	K232954	BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel	QOF	2024-03-26	Ver
510(k)	K230719	BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini	QOF	2023-04-13	Ver
510(k)	K230404	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel	PCH	2023-03-16	Ver
510(k)	K222601	FilmArray Pneumonia Panel plus	QDS	2022-10-27	Ver
510(k)	K212727	FilmArray Pneumonia Panel	QDP	2021-09-22	Ver
510(k)	K193519	BioFire Blood Culture Identification 2 (BCID2) Panel	PEN	2020-03-18	Ver
510(k)	K181324	FilmArray Pneumonia Panel plus	QDS	2018-11-15	Ver
510(k)	K180966	FilmArray Pneumonia Panel	QDP	2018-11-09	Ver
510(k)	K181493	FilmArray Blood Culture Identification (BCID) Panel	PEN	2018-07-05	Ver
510(k)	K170604	FilmArray Respiratory Panel 2 (RP2)	OCC	2017-05-30	Ver
510(k)	K152579	FilmArray Respiratory Panel EZ (RP EZ)	OCC	2016-10-03	Ver
510(k)	K160459	FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch	PCH	2016-04-01	Ver
510(k)	K160462	FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch	PLO	2016-03-17	Ver
510(k)	K160457	FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch	PEN	2016-03-15	Ver
510(k)	K160068	FilmArray Respiratory Panel (RP) for use with FilmArray Torch	OCC	2016-02-08	Ver