This page includes the latest FDA filings for VENTANA MEDICAL SYSTEMS, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Manufacturer | Device Name | Date |
|---|---|---|
Ventana Medical Systems, Inc. | VENTANA CD30 (Ber-H2) RxDx Assay | 2018-05-08 |
| PMA | Manufacturer | Device Name | Date |
|---|---|---|---|
VENTANA MEDICAL SYSTEMS, INC. | Ventana PD-Ll (SP142) Assay | 2019-11-19 | |
VENTANA MEDICAL SYSTEMS, INC. | Inform HER2 Dual ISH DNA Probe Cocktail | 2019-11-19 | |
Ventana Medical Systems, Inc. | Ventana PD-Ll (SP263) Assay | 2019-11-19 | |
VENTANA MEDICAL SYSTEMS, INC. | Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody | 2019-11-19 | |
VENTANA MEDICAL SYSTEMS, INC. | Ventana ALK (D5F3) CDx Assay | 2019-11-19 | |
VENTANA MEDICAL SYSTEMS, INC. | PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody | 2019-05-06 | |
VENTANA MEDICAL SYSTEMS, INC. | INFORM HER2 Dual ISH DNA Probe Cocktail assays | 2019-05-03 | |
VENTANA MEDICAL SYSTEMS, INC. | PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2019-05-03 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA PD-L1(SP142) Assay. | 2019-03-08 | |
VENTANA MEDICAL SYSTEMS, INC. | Ventana ALK (D5f3) CDx Assay | 2018-12-07 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA PD-L1(SP142) Assay | 2018-09-13 | |
VENTANA MEDICAL SYSTEMS, INC. | PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2018-09-13 | |
Ventana Medical Systems, Inc. | VENTANA PD-L1 (SP263) Assay | 2018-09-13 | |
VENTANA MEDICAL SYSTEMS, INC. | INFORM HER2 Dual ISH DNA Probe Cocktail | 2018-09-13 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA ALK (D5F3) CDx Assay | 2018-09-13 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA PD-L1(SP142) CDX ASSAY | 2018-07-02 | |
Ventana Medical Systems, Inc. | Ventana PD-L1 (SP263) | 2018-06-01 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA ALK (D5F3) CDx Assay | 2017-11-06 | |
Ventana Medical Systems, Inc. | Ventana PD-L1 (SP263) Assay | 2017-08-04 | |
VENTANA MEDICAL SYSTEMS, INC. | Inform HER2 Dual ISH DNA Probe Cocktail | 2017-08-04 | |
VENTANA MEDICAL SYSTEMS, INC. | Ventana ALK (D5F3) CDx Assay | 2017-08-04 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA ALK (D5F3) CDX ASSAY | 2017-05-26 | |
Ventana Medical Systems, Inc. | VENTANA PD-L1 (SP263) ASSAY | 2017-05-01 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA ALK (D5F3) | 2017-03-13 | |
VENTANA MEDICAL SYSTEMS, INC. | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2017-03-13 | |
VENTANA MEDICAL SYSTEMS, INC. | INFORM HER2 Dual ISH DNA Probe Cocktail | 2017-03-13 | |
VENTANA MEDICAL SYSTEMS, INC. | Ventana Pd-l1(sp142) Cdx Assay | 2016-12-21 | |
VENTANA MEDICAL SYSTEMS, INC. | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL | 2016-11-30 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA ALK (D5F3) CDX ASSAY | 2016-10-21 | |
VENTANA MEDICAL SYSTEMS, INC. | VENTANA PD-L1(SP142) CDX ASSAY | 2016-05-18 |
| De Novo | Manufacturer | Device Name | Date |
|---|---|---|---|
Ventana Medical Systems | VENTANA Anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA Anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA Anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primar | 2017-10-27 |
Device GUDID Device Name | Manufacturer | Date |
|---|---|---|
VIRTUOSO System for IHC | VENTANA MEDICAL SYSTEMS, INC. | 2019-11-27 |
VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Pri | Ventana Medical Systems, Inc. | 2018-07-06 |
VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary | Ventana Medical Systems, Inc. | 2018-07-06 |
VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Pri | Ventana Medical Systems, Inc. | 2018-07-06 |
VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primar | Ventana Medical Systems, Inc. | 2018-07-06 |
VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary An | Ventana Medical Systems, Inc. | 2018-07-06 |