|
Device |
reagent, coronavirus serological |
Definition |
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens. |
Product Code | QKO |
Device Class |
Not Classified
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AZURE BIOTECH INC |
II |
Apr-16-2021 |
2 |
Ansh Labs, LLC |
II |
Jan-11-2021 |
3 |
Beckman Coulter Inc. |
II |
Sep-22-2021 |
4 |
Beckman Coulter Inc. |
II |
Jun-21-2021 |
5 |
Beckman Coulter Inc. |
II |
Jan-15-2021 |
6 |
Chembio Diagnostics, Inc |
II |
Aug-14-2020 |
7 |
Confirm Biosciences Inc |
II |
Feb-16-2021 |
8 |
Empowered Diagnostics LLC |
I |
Jan-29-2022 |
9 |
Epitope Diagnostics, Inc. |
II |
Nov-06-2020 |
10 |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
I |
May-28-2021 |
11 |
LumiraDx |
II |
Jul-22-2022 |
12 |
Lusys Laboratories, Inc. |
I |
Mar-10-2022 |
13 |
Ortho Clinical Diagnostics |
II |
Aug-07-2020 |
14 |
Ortho Clinical Diagnostics Inc |
II |
Oct-15-2021 |
15 |
Ortho-Clinical Diagnostics, Inc. |
II |
Apr-18-2023 |
16 |
Ortho-Clinical Diagnostics, Inc. |
II |
Jul-12-2022 |
17 |
PROTERIXBIO |
II |
May-11-2022 |
18 |
Sky Medical Supplies and Equipments LLC |
II |
Feb-16-2021 |
19 |
Thera Test Laboratories, Inc. |
II |
Aug-27-2021 |
20 |
Thera Test Laboratories, Inc. |
II |
Aug-27-2021 |
21 |
Universal Meditech Inc. |
II |
Oct-23-2023 |
22 |
Versea Diagnostics LLC |
II |
Sep-03-2021 |
23 |
bioMerieux, Inc. |
II |
Dec-28-2021 |
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