Product code PLS ยท Class 3
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in PLS
| Company | 510(k)s | Recalls |
|---|---|---|
| Dako North America Inc. | 0 | 1 |
| Ventana Medical Systems, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2023 | Ventana Medical Systems, Inc. VENTANA PD-L1 (SP142)
VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001
VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001
VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011 Open, Classified |
PLS | None listed |
| Feb 2, 2018 | Dako North America Inc. PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options. Terminated |
PLS | None listed |
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