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)
Top companies in PEN
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, Inc. | 6 | 13 |
| Nanosphere, Inc. | 1 | 4 |
| Luminex Corporation | 1 | 3 |
| Genmark Diagnostics, Incorporated | 2 | 0 |
| Icubate, Inc. | 1 | 0 |
| QIAGEN GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2025 | Luminex 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 |
PEN | K132843 |
| Jul 31, 2024 | BioFire 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 |
PEN | K193519 |
| Feb 15, 2024 | BioFire 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 |
PEN | K193519 |
| Dec 1, 2023 | BioFire 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 |
PEN | K193519 |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
BioFire BCID2 Panel - REF RFIT-ASY-0147 Open, Classified |
PEN | K193519 |
| Oct 11, 2021 | BioFire 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 |
PEN | K193519 |
| Jul 20, 2021 | BioFire 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 |
PEN | K181493 |
| May 10, 2021 | BioFire 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 |
PEN | K193519 |
| Jan 26, 2021 | BioFire Diagnostics, LLC BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems. Terminated |
PEN | K193519 |
| Jan 26, 2021 | BioFire 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 |
PEN | K181493 |
| Oct 13, 2020 | Luminex 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 |
PEN | K143653 |
| Jun 15, 2020 | Luminex 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 |
PEN | K132843 |
| Jan 22, 2020 | BioFire 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 |
PEN | K130914 K143171 +2 |
| Jan 22, 2020 | BioFire 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 |
PEN | K130914 K143171 +2 |
| Mar 7, 2019 | BioFire 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 |
PEN | K130914 K143171 +2 |
| Apr 25, 2018 | BioFire 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 |
PEN | K130914 K143171 +1 |
| Sep 30, 2014 | Nanosphere, 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 |
PEN | K132843 |
| Sep 23, 2014 | Nanosphere, 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 |
PEN | K132843 |
| Aug 14, 2014 | Nanosphere, 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 |
PEN | K132843 |
| Aug 8, 2014 | Nanosphere, 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 |
PEN | K132843 |
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