|
Device |
gram-negative bacteria and associated resistance markers |
Definition |
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures. |
Product Code | PEN |
Regulation Number |
866.3365
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
BioFire Diagnostics, LLC |
II |
Feb-15-2024 |
2 |
BioFire Diagnostics, LLC |
II |
Dec-01-2023 |
3 |
BioFire Diagnostics, LLC |
II |
Mar-15-2023 |
4 |
BioFire Diagnostics, LLC |
II |
Nov-30-2021 |
5 |
BioFire Diagnostics, LLC |
II |
Aug-12-2021 |
6 |
BioFire Diagnostics, LLC |
II |
Jun-21-2021 |
7 |
BioFire Diagnostics, LLC |
II |
Mar-01-2021 |
8 |
BioFire Diagnostics, LLC |
II |
Jun-08-2020 |
9 |
BioFire Diagnostics, LLC |
II |
Apr-12-2019 |
10 |
BioFire Diagnostics, LLC |
II |
Apr-25-2018 |
11 |
Luminex Corporation |
II |
Nov-20-2020 |
12 |
Luminex Corporation |
II |
Aug-10-2020 |
13 |
Nanosphere, Inc. |
II |
Sep-30-2014 |
14 |
Nanosphere, Inc. |
II |
Sep-23-2014 |
15 |
Nanosphere, Inc. |
II |
Aug-14-2014 |
16 |
Nanosphere, Inc. |
II |
Aug-08-2014 |
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