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Panels › Microbiology › Product code PEN · Class 2

Gram-Negative Bacteria And Associated Resistance Markers

Regulation 866.3365

1510(k)s in 12 months (12 all time)
0recalls in 12 months (20 all time)
20recalls that name a 510(k)
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Top companies in PEN

DateFirm and productCodeLinked 510(k)
Jun 3, 2025Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Completed
PENK132843
Jul 31, 2024BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF
Open, Classified
PENK193519
Feb 15, 2024BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTE
Open, Classified
PENK193519
Dec 1, 2023BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Con
Open, Classified
PENK193519
Mar 15, 2023BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Open, Classified
PENK193519
Oct 11, 2021BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD
Terminated
PENK193519
Jul 20, 2021BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Terminated
PENK181493
May 10, 2021BioFire Diagnostics, LLC
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Terminated
PENK193519
Jan 26, 2021BioFire Diagnostics, LLC
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
Terminated
PENK193519
Jan 26, 2021BioFire Diagnostics, LLC
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-
Terminated
PENK181493
Oct 13, 2020Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, whi
Terminated
PENK143653
Jun 15, 2020Luminex Corporation
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver
Terminated
PENK132843
Jan 22, 2020BioFire Diagnostics, LLC
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BAC
Terminated
PENK130914
K143171 +2
Jan 22, 2020BioFire Diagnostics, LLC
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BA
Terminated
PENK130914
K143171 +2
Mar 7, 2019BioFire Diagnostics, LLC
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/4
Terminated
PENK130914
K143171 +2
Apr 25, 2018BioFire Diagnostics, LLC
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catal
Terminated
PENK130914
K143171 +1
Sep 30, 2014Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gr
Terminated
PENK132843
Sep 23, 2014Nanosphere, Inc.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous det
Terminated
PENK132843
Aug 14, 2014Nanosphere, Inc.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions,
Terminated
PENK132843
Aug 8, 2014Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detecti
Terminated
PENK132843

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