Device |
immunohistochemistry assay, antibody, folr1 |
Regulation Description |
Immunohistochemistry reagents and kits. |
Definition |
The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. |
Product Code | QUL |
Regulation Number |
864.1860
|
Device Class |
3
|
Premarket Approvals (PMA) |
2020 |
2021 |
2022 |
2023 |
2024 |
2025 |
0
|
0
|
1
|
3
|
1
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2024 |
1 |
1 |
|
|
|