|
Device |
immunohistochemistry reagents and kits |
Definition |
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. |
Product Code | NJT |
Regulation Number |
864.1860
|
Device Class |
1
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AMS Diagnostics, LLC |
II |
Mar-21-2014 |
2 |
Biocare Medical Llc |
II |
Jan-13-2015 |
3 |
Biocare Medical Llc |
II |
Apr-10-2012 |
4 |
Biocare Medical, LLC |
II |
Jun-05-2020 |
5 |
Biocare Medical, LLC |
II |
Sep-19-2018 |
6 |
Biocare Medical, LLC |
II |
Jul-05-2018 |
7 |
Biocare Medical, LLC |
III |
Apr-19-2016 |
8 |
Biocare Medical, LLC |
II |
Nov-09-2015 |
9 |
Biocare Medical, LLC |
III |
May-26-2015 |
10 |
Biocare Medical, LLC |
II |
Apr-27-2015 |
11 |
Cell Marque Corporation |
III |
Aug-18-2021 |
12 |
Cell Marque Corporation |
II |
Jun-17-2016 |
13 |
Cell Marque Corporation |
II |
Mar-06-2012 |
14 |
Cell Marque Corporation |
III |
Aug-31-2011 |
15 |
Lab Vision Corporation |
III |
Feb-17-2016 |
16 |
Lab Vision Corporation |
II |
Feb-22-2012 |
17 |
Lab Vision Corporation |
II |
Sep-15-2010 |
18 |
Leica Biosystems Newcastle Ltd. |
II |
Jan-10-2014 |
19 |
Leica Biosystems Richmond Inc. |
II |
Sep-12-2017 |
20 |
Leica Microsystems, Inc. |
II |
Sep-16-2021 |
21 |
Leica Microsystems, Inc. |
II |
Dec-12-2019 |
22 |
Leica Microsystems, Inc. |
II |
Jun-01-2016 |
23 |
Leica Microsystems, Inc. |
II |
May-21-2016 |
24 |
Leica Microsystems, Inc. |
II |
Feb-19-2016 |
25 |
Leica Microsystems, Inc. |
II |
Feb-12-2016 |
26 |
Leica Microsystems, Inc. |
II |
Nov-25-2015 |
27 |
Leica Microsystems, Inc. |
II |
Mar-24-2015 |
28 |
Leica Microsystems, Inc. |
II |
Nov-06-2014 |
29 |
Leica Microsystems, Inc. |
II |
Jun-04-2014 |
30 |
Leica Microsystems, Inc. |
II |
Jun-02-2014 |
31 |
Leica Microsystems, Inc. |
II |
Dec-13-2012 |
32 |
Leica Microsystems, Inc. |
II |
Feb-17-2012 |
33 |
Leica Microsystems, Inc. |
III |
Sep-09-2011 |
34 |
Leica Microsystems, Inc. |
II |
Feb-09-2011 |
35 |
Leica Microsystems, Inc. |
II |
Sep-25-2010 |
36 |
Ventana Medical Systems Inc |
I |
Sep-14-2018 |
37 |
Ventana Medical Systems Inc |
I |
Feb-27-2018 |
38 |
Ventana Medical Systems, Inc. |
II |
Aug-16-2024 |
|
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