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Ventana Medical Systems, Inc.

48 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Roche Digital Pathology Dx (K242783)Ventana Medical Systems, Inc.2024-12-17
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025)Ventana Medical Systems, Inc.2024-12-05
Roche Digital Pathology Dx (VENTANA DP 200) (K232879)Ventana Medical Systems, Inc.2024-06-14
CINtec Histology (K212176)Ventana Medical Systems, Inc.2021-12-10
VENTANA CD30 (Ber-H2) RxDx Assay (K172471)Ventana Medical Systems, Inc.2018-05-08
CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019)Ventana Medical Systems, Inc.2017-03-04
Virtuoso System for IHC PR (1E2) using iScan HT (K142965)Ventana Medical Systems, Inc.2015-07-16
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465)Ventana Medical Systems, Inc.2014-03-20
VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515)Ventana Medical Systems, Inc.2013-11-22
VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516)Ventana Medical Systems, Inc.2013-09-26
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (K122143)Ventana Medical Systems, Inc.2013-09-19
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033)Ventana Medical Systems, Inc.2013-09-06
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215)Ventana Medical Systems, Inc.2012-12-17
VIRTUSO SYSTEM FOR IHC (DO-7) (K121350)Ventana Medical Systems, Inc.2012-06-01
VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (K111872)Ventana Medical Systems, Inc.2012-04-19
VIRTUOSO SYSTEM FOR IHC PR (IE2) (K111869)Ventana Medical Systems, Inc.2012-03-05
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755)Ventana Medical Systems, Inc.2012-02-22
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543)Ventana Medical Systems, Inc.2011-10-12
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234)Ventana Medical Systems, Inc.2011-08-25
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618)Ventana Medical Systems, Inc.1999-07-23
VENTANA CD45 PRIMARY ANTIBODY (K940583)Ventana Medical Systems, Inc.1997-10-20
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING (K973389)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE LAMBDA (K973392)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE KAPPA (K973391)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE L26 (CD20) (K973390)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE LCA (K973393)Ventana Medical Systems, Inc.1997-09-25
VENTANA ANTI-S100 PRIMARY ANTIBODY (K941514)Ventana Medical Systems, Inc.1997-04-25
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY (K941170)Ventana Medical Systems, Inc.1997-04-22
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY (K941707)Ventana Medical Systems, Inc.1997-04-21
VENTANA ANTI-CD8 PRIMARY ANTIBODY (K941784)Ventana Medical Systems, Inc.1997-02-14
VENTANA ANTI-CD4 PRIMARY ANTIBODY (K941604)Ventana Medical Systems, Inc.1997-02-14
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY (K941516)Ventana Medical Systems, Inc.1997-02-10
ANTI-VIMENTIN PRIMARY ANTIBODY (K941397)Ventana Medical Systems, Inc.1997-02-10
VENTANA CEA PRIMARY ANTIBODY (K940242)Ventana Medical Systems, Inc.1996-12-23
VENTANA ANTI-CD5 PRIMARY ANTIBODY (K941782)Ventana Medical Systems, Inc.1996-09-10
VENTANNA ANTI-CD3 PRIMARY ANTIBODY (K941505)Ventana Medical Systems, Inc.1996-05-30
ANTI-KERATIN-HMW PRIMARY ANTI-BODY (K941173)Ventana Medical Systems, Inc.1996-03-22
KERATIN PRIMARY ANTIBODY (K935161)Ventana Medical Systems, Inc.1996-03-22
KERATIN PRIMARY ANTIBODY (K940331)Ventana Medical Systems, Inc.1996-02-26
VENTANA BLUE DETECTION KIT (K940424)Ventana Medical Systems, Inc.1995-11-06
VENTANA EMA PRIMARY ANDIBODY (K940243)Ventana Medical Systems, Inc.1994-09-07
VENTANA NEGATIVE CONTROL REAGENT (K931979)Ventana Medical Systems, Inc.1994-03-30
VENTANA RED DETECTION KIT (K932386)Ventana Medical Systems, Inc.1993-08-09
PSA ANTIBODY KIT (K932326)Ventana Medical Systems, Inc.1993-08-06
PSA ANTIBODY KIT (K924578)Ventana Medical Systems, Inc.1993-02-05
PAP ANTIBODY KIT (K924629)Ventana Medical Systems, Inc.1993-02-04
DAB DETECTION KIT (K920600)Ventana Medical Systems, Inc.1992-05-11
AEC DETECTION KIT (K920566)Ventana Medical Systems, Inc.1992-05-08

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