Company ยท US
Ventana Medical Systems Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2024. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
56recalls (1 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 19 |
| DEH | Lambda, Antigen, Antiserum, Control | 17 |
| KPA | Slide Stainer, Automated | 11 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 7 |
| PPM | General Purpose Reagent | 6 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 5 |
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | 5 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 4 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 4 |
| DEY | Igm, Peroxidase, Antigen, Antiserum, Control | 3 |
| DFD | Kappa, Peroxidase, Antigen, Antiserum, Control | 3 |
| PSY | Whole Slide Imaging System | 3 |
| KEY | Stainer, Tissue, Automated | 2 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 2 |
| OWF | Immunohistochemical Assay, Helicobacter Pylori | 2 |
| DHF | D/Km-1, Antigen, Antiserum, Control | 1 |
| HYJ | Hematoxylin | 1 |
| IBG | Trypsin | 1 |
| KTO | Reagent, Immunoassay, Igg | 1 |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2024 | K242783 | Roche Digital Pathology Dx Ventana Medical Systems, Inc. | PSY |
| Dec 5, 2024 | DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) Ventana Medical Systems, Inc. | SDP |
| Jun 14, 2024 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) Ventana Medical Systems, Inc. | PSY |
| Dec 10, 2021 | K212176 | CINtec Histology Ventana Medical Systems, Inc. | PRB |
| May 8, 2018 | K172471 | VENTANA CD30 (Ber-H2) RxDx Assay Ventana Medical Systems, Inc. | DEH |
| Oct 27, 2017 | DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, V Ventana Medical Systems | PZJ |
| Mar 4, 2017 | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) Ventana Medical Systems, Inc. | PRB |
| Jul 16, 2015 | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT Ventana Medical Systems, Inc. | OEO |
| Mar 20, 2014 | K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. | NQN |
| Nov 22, 2013 | K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) Ventana Medical Systems, Inc. | NQN |
| Sep 26, 2013 | K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. | NQN |
| Sep 19, 2013 | K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. | NQN |
| Sep 6, 2013 | K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. | NOT |
| Dec 17, 2012 | K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc. | MYA |
| Jun 1, 2012 | K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) Ventana Medical Systems, Inc. | NOT |
| Apr 19, 2012 | K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) Ventana Medical Systems, Inc. | NQN |
| Mar 5, 2012 | K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) Ventana Medical Systems, Inc. | NQN |
| Feb 22, 2012 | K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. | NOT |
| Oct 12, 2011 | K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. | NOT |
| Aug 25, 2011 | K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc. | OWF |
| Jul 23, 1999 | K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) Ventana Medical Systems, Inc. | MXZ |
| Oct 20, 1997 | K940583 | VENTANA CD45 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Oct 3, 1997 | K973392 | CHEMMATE LAMBDA Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973391 | CHEMMATE KAPPA Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973390 | CHEMMATE L26 (CD20) Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING Ventana Medical Systems, Inc. | DEM |
| Sep 25, 1997 | K973393 | CHEMMATE LCA Ventana Medical Systems, Inc. | DEH |
| Apr 25, 1997 | K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Apr 22, 1997 | K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Apr 21, 1997 | K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 14, 1997 | K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 14, 1997 | K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 10, 1997 | K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 10, 1997 | K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Dec 23, 1996 | K940242 | VENTANA CEA PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DFD |
| Sep 10, 1996 | K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| May 30, 1996 | K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Mar 22, 1996 | K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY Ventana Medical Systems, Inc. | DEH |
| Mar 22, 1996 | K935161 | KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 26, 1996 | K940331 | KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Nov 6, 1995 | K940424 | VENTANA BLUE DETECTION KIT Ventana Medical Systems, Inc. | DEH |
| Sep 7, 1994 | K940243 | VENTANA EMA PRIMARY ANDIBODY Ventana Medical Systems, Inc. | DHF |
| Mar 30, 1994 | K931979 | VENTANA NEGATIVE CONTROL REAGENT Ventana Medical Systems, Inc. | DEM |
| Aug 9, 1993 | K932386 | VENTANA RED DETECTION KIT Ventana Medical Systems, Inc. | DEY |
| Aug 6, 1993 | K932326 | PSA ANTIBODY KIT Ventana Medical Systems, Inc. | DEH |
| Feb 5, 1993 | K924578 | PSA ANTIBODY KIT Ventana Medical Systems, Inc. | DFD |
| Feb 4, 1993 | K924629 | PAP ANTIBODY KIT Ventana Medical Systems, Inc. | DFD |
| May 11, 1992 | K920600 | DAB DETECTION KIT Ventana Medical Systems, Inc. | DEY |
| May 8, 1992 | K920566 | AEC DETECTION KIT Ventana Medical Systems, Inc. | DEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Ventana Medical Systems, Inc. navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5. Material Number 09453733001
UDI-DI Code: 761333602095AQ
In the United States, navify Dig Open, Classified |
PSY | K232879 K242783 |
| Aug 16, 2024 | Ventana Medical Systems, Inc. Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD Open, Classified |
NJT | None listed |
| 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 |
| Jul 12, 2022 | Ventana Medical Systems Inc Ventana HE 600 System, automated slide preparer, for use in laboratories. Open, Classified |
KPA | None listed |
| Apr 8, 2022 | Ventana Medical Systems Inc BenchMark ULTRA and DISCOVERY ULTRA Instruments Open, Classified |
KPA | None listed |
| Oct 4, 2019 | Ventana Medical Systems Inc Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, Completed |
KPA | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MAQ | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec Histology (250), Catalog Number 06680011001, model 725-4793
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
OWF | K101234 |
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MYA | K110215 |
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MXZ | K103818 |
| Sep 14, 2018 | Ventana Medical Systems Inc ISH Protease 3, Catalog Number 05273331001, model 780-4149
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
IBG | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093.
For laboratory use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc iView DAB Detection Kit, Catalog Number 05266157001, model 760-091
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic Terminated |
HYJ | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic Terminated |
NJT | None listed |
| Aug 28, 2013 | Ventana Medical Systems Inc Benchmark XT/LT and Discovery XT
Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS.
Product Usage: Usage:
The Benchmark product lines are intended to automaticall Terminated |
KPA | None listed |
| Aug 6, 2013 | Ventana Medical Systems Inc VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only
Product Usage:
Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically st Terminated |
KPA | None listed |
| Aug 6, 2013 | Ventana Medical Systems Inc VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only
Product Usage:
Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically st Terminated |
KPA | None listed |
| Jul 1, 2011 | Ventana Medical Systems Inc iView DAB Detection Kit, Part number: 760-091
(05266157001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect bioti Terminated |
MYA | K984567 K990618 |
| Jul 1, 2011 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an Terminated |
MYA | K984567 K990618 |
| Mar 16, 2010 | Ventana Medical Systems Inc VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
(PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic. Terminated |
MVC | None listed |
| Mar 18, 2008 | Ventana Medical Systems Inc Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Sy Terminated |
NQN | K061613 |
| Jan 25, 2008 | Ventana Medical Systems Inc Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc Terminated |
KEY | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
Newest 50 of 56.