Ventana Medical Systems, Inc

FDA Filings

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.

Latest Premarket Notifications

ManufacturerDevice NameDate
Ventana Medical Systems, Inc.
VENTANA CD30 (Ber-H2) RxDx Assay2018-05-08

Latest Premarket Applications

PMAManufacturerDevice NameDate
Ventana Medical Systems, Inc.
Ventana PD-Ll (SP263) Assay2019-11-19
VENTANA MEDICAL SYSTEMS, INC.
Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody2019-11-19
VENTANA MEDICAL SYSTEMS, INC.
Ventana ALK (D5F3) CDx Assay2019-11-19
VENTANA MEDICAL SYSTEMS, INC.
Ventana PD-Ll (SP142) Assay2019-11-19
VENTANA MEDICAL SYSTEMS, INC.
Inform HER2 Dual ISH DNA Probe Cocktail2019-11-19
VENTANA MEDICAL SYSTEMS, INC.
PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody2019-05-06
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody2019-05-03
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail assays2019-05-03
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1(SP142) Assay.2019-03-08
VENTANA MEDICAL SYSTEMS, INC.
Ventana ALK (D5f3) CDx Assay2018-12-07
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1(SP142) Assay2018-09-13
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail2018-09-13
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody2018-09-13
Ventana Medical Systems, Inc.
VENTANA PD-L1 (SP263) Assay2018-09-13
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDx Assay2018-09-13
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1(SP142) CDX ASSAY2018-07-02
Ventana Medical Systems, Inc.
Ventana PD-L1 (SP263)2018-06-01
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDx Assay2017-11-06
VENTANA MEDICAL SYSTEMS, INC.
Inform HER2 Dual ISH DNA Probe Cocktail2017-08-04
Ventana Medical Systems, Inc.
Ventana PD-L1 (SP263) Assay2017-08-04
VENTANA MEDICAL SYSTEMS, INC.
Ventana ALK (D5F3) CDx Assay2017-08-04
VENTANA MEDICAL SYSTEMS, INC.
Ventana PD-L1 (SP142) Assay2017-08-04
VENTANA MEDICAL SYSTEMS, INC.
Ventana PD-L1 (SP142) Assay2017-06-06
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDX ASSAY2017-05-26
Ventana Medical Systems, Inc.
VENTANA PD-L1 (SP263) ASSAY2017-05-01
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3)2017-03-13
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail2017-03-13
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody2017-03-13
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1(SP142) CDX ASSAY2016-12-21
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL2016-11-30

Latest De Novo Filings

De NovoManufacturerDevice NameDate
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 Primar2017-10-27

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
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

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