Panels › Microbiology › Product code PAM · Class 2
Gram-Positive Bacteria And Their Resistance Markers
Regulation 866.3365
1510(k)s in 12 months (7 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in PAM
| Company | 510(k)s | Recalls |
|---|---|---|
| Luminex Corporation | 1 | 6 |
| Nanosphere, Inc. | 2 | 2 |
| BioFire Diagnostics, Inc. | 0 | 2 |
| Great Basin Scientific, Inc. | 1 | 1 |
| Genmark Diagnostics, Incorporated | 1 | 0 |
| Icubate, Inc. | 1 | 0 |
| QIAGEN GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2024 | Luminex Corporation Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Open, Classified |
PAM | K122514 |
| Dec 6, 2023 | Luminex Corporation Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 2 Open, Classified |
PAM | K122514 |
| Oct 13, 2020 | Luminex Corporation Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, whi Terminated |
PAM | K143653 |
| Jun 15, 2020 | Luminex Corporation Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver Terminated |
PAM | K122514 |
| Feb 11, 2019 | Luminex Corporation Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018
The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, m Terminated |
PAM | K122514 |
| Nov 10, 2018 | Luminex Corporation VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits
(packaged as five-pack carriers)
Product Usage:
In vitro diagnostic test for the simultaneous detection and identification of potentially patho Terminated |
PAM | K122514 |
| Oct 30, 2018 | BioFire Diagnostics, LLC FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:
RFIT-ASY-0126 (30 test kit)/ 00815381020086,
RFIT-ASY-0127 (6 test kit)/ 00815381020 Terminated |
PAM | K130914 K143171 +2 |
| Jan 19, 2017 | Great Basin Scientific, Inc. Great Basin Staph lD/R Blood Culture Panel
The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer Sys Terminated |
PAM | K152470 |
| Sep 30, 2014 | Nanosphere, Inc. Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gr Terminated |
PAM | K122514 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous dete Terminated |
PAM | K122514 |
| Jun 20, 2014 | BioFire Diagnostics, Inc. FirmArray Blood Culture Identification (BCID) Panel, Model 2.0
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designe Terminated |
PAM | K130914 |
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