FDA.reportPublic FDA data

VENTANA MEDICAL SYSTEMS, INC.

Matched from indexed company URL: VENTANA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20284921000125183VENTANA MEDICAL SYSTEMS, INC.1N2026-01-011910 EAST INNOVATION PARK DR. Tucson AZ US 85755

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2009011898816217P990081PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODYMVC2000-11-28
2009011500327122P240037VENTANA MET (SP44) RxDx AssaySER2025-05-14
2009011790705340P230018VENTANA CLDN18 (43-14A) RxDx AssayQZJ2024-10-18
2009011671148788P220006VENTANA FOLR1 (FOLR-2.1) RxDx AssayQUL2022-11-14
2009011092257352P210001VENTANA MMR RxDx PanelQNH2021-08-17
2009011043844839P200019VENTANA MMR RxDx PanelQNH2021-04-22
2009011576058275P190031HER2 Dual ISH DNA Probe CocktailNYQ2020-07-28
2009011262145447P190024CINtec PLUS CytologyQKF2020-03-10
2009012065010328P160046VENTANA PD-L1 (SP263) ASSAYPLS2017-05-01
2009011908079727P160006VENTANA PD-L1 (SP142) AssayPLS2016-10-18
2009011824460781P160002VENTANA PD-L1(SP142) CDX ASSAYPLS2016-05-18
2009011400256471P140025VENTANA ALK (D5F3) CDX ASSAYPKW2015-06-12
2009011002225005P100027INFORM HER2 DUAL ISH DNA PROBE COCKTAILNYQ2011-06-14
2009011942171308P020055VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODYNKF2004-08-11
2009011897476960K242783Roche Digital Pathology DxPSY2024-12-17
2009011677831841K232879Roche Digital Pathology Dx (VENTANA DP 200)PSY2024-06-14
2009011490143243K142965Virtuoso System for IHC PR (1E2) using iScan HTOEO2015-07-16
2009011125596642K140465VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINERNQN2014-03-20
2009011486161181K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)NQN2013-11-22
2009011343181147K122143VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERNQN2013-09-19
2009011413264070K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)NQN2013-09-26
2009012064397781K121350VIRTUSO SYSTEM FOR IHC (DO-7)NOT2012-06-01
2009011554260012K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)NOT2013-09-06
2009011952925473K111872VIRTUOSO SYSTEM FOR IHC P53 (DO-7)NQN2012-04-19
2009012061873219K111869VIRTUOSO SYSTEM FOR IHC PR (IE2)NQN2012-03-05
2009011801587429K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)NOT2012-02-22
2009011828870196K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)NOT2011-10-12
2009011041655433K110215CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYMYA2012-12-17
2009011321025057K103818CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODYMXZ2011-11-16
2009012055265026K101234VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYOWF2011-08-25
2009011762811950DEN240025VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)SDP2024-12-05
2009012061651689DEN170030VENTANA 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 Primary AntibodyPZJ2017-10-27
2009011503545371DEN160019CINtec Histology (50 tests), CINtec Histology (250 tests)PRB2017-03-04
2009011042066657
2009011118697313
2009011496862023
2009011557491714
2009011584436848
2009011733467805
2009011760444759
2009012009474986
2009012030995179
2009012061129485
2009011059784457
2009011102751767
2009011121524786
2009011124187555
2009011170569229
2009011185703378
2009011217411149
2009011272961820
2009011317542115
2009011337742726
2009011342125534
2009011348781273
2009011365679858
2009011367743876
2009011384732735
2009011398820130
2009011401775080
2009011412904008
2009011439693033
2009011443867833
2009011448197294
2009011484850392
2009011486489634
2009011530137072
2009011546775874
2009011603689258
2009011620659575
2009011648664374
2009011667666992
2009011691612481
2009011693969989
2009011698415749
2009011701543467
2009011704834194
2009011714589919
2009011731976693
2009011736594003
2009011739569120
2009011848037266
2009011851333679
2009011915203318
2009011923906176
2009011942875281
2009012065003441

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQN62014-03-20
NOT42013-09-06
PSY22024-12-17
QNH 22021-08-17
PLS22017-05-01
SDP12024-12-05
QUL 12022-11-14
NYQ 12020-07-28
QKF 12020-03-10
PZJ12017-10-27
PRB12017-03-04
PLS 12016-10-18
OEO12015-07-16
PKW12015-06-12
MYA12012-12-17
MXZ12011-11-16
OWF12011-08-25
NYQ12011-06-14
NKF 12004-08-11
MVC12000-11-28

PMA#

CINtec PLUS Cytology

2023-01-30

Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS009 Date Received01/03/2023 Decision Date01/30/2023 Product Code QKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason P...

VENTANA FOLR1 (FOLR-2.1) RxDx Assay

2022-11-14

Ventana Medical Systems Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP220006 Date Received04/25/2022 Decision Date11/14/2022 Product Code QUL  Advisory Committee Clinical TrialsNCT04296890 Expedited Review Granted? No

VENTANA PD-L1 (SP263) Assay

2022-11-10

Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS015 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Man...

INFORM HER2 Dual ISH DNA Probe Cocktail

2022-11-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS038 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Man...

CINtec PLUS Cytology

2022-11-10

Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS008 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Ma...

PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

2022-11-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS050 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Man...

VENTANA PD-L1 (SP142) Assay

2022-11-10

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS019 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - M...

PATHWAY Anti-c-KIT (9.7) Primary Antibody

2022-11-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS028 Date Received10/14/2022 Decision Date11/10/2022 Product Code NKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Pr...

VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)

2022-11-10

Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS007 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement ...

VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

2022-11-10

Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS006 Date Received10/14/2022 Decision Date11/10/2022 Product Code QNH  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process...

VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

2022-07-29

Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS005 Date Received07/12/2022 Decision Date07/29/2022 Product Code QNH  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process...

VENTANA HER2 Dual ISH DNA Probe Cocktail

2022-07-29

Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS005 Date Received07/12/2022 Decision Date07/29/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason ...

PATHWAY Anti-c-KIT (9.7) Primary Antibody

2022-07-29

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS027 Date Received07/12/2022 Decision Date07/29/2022 Product Code NKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Pr...

PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

2022-07-29

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS048 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Man...

INFORM HER2 Dual ISH DNA Probe Cocktail

2022-07-29

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS037 Date Received07/12/2022 Decision Date07/29/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Pr...

VENTANA PD-L1 (SP142) Assay

2022-07-29

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS018 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - M...

VENTANA ALK (D5F3) CDx Assay

2022-07-29

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS018 Date Received07/12/2022 Decision Date07/29/2022 Product Code PKW  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason ...

VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)

2022-07-29

Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS006 Date Received07/12/2022 Decision Date07/29/2022 Product Code QNH  Advisory Committee Pathology Supplement Type30-day ...

CINtec PLUS Cytology

2022-07-29

Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS007 Date Received07/12/2022 Decision Date07/29/2022 Product Code QKF  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason P...

VENTANA PD-L1 (SP263) Assay

2022-07-29

Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS014 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Man...

VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

2022-07-21

Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Re...

VENTANA ALK (D5F3) CDx Assay

2022-07-21

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supple...

PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

2022-07-21

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS046 Date Received02/16/2022 Decision Date07/21/2022 Product Code MVC  Advisory Committee Pathology Supplement Typespecial (immediate Track) Suppleme...

CINtec PLUS Cytology

2022-07-21

Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS006 Date Received02/16/2022 Decision Date07/21/2022 Product Code QFK  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplem...

VENTANA PD-Ll (SP263) Assay

2022-07-21

Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS012 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  Advisory Committee Pathology Supplement Typespecial (immediate Track) Suppleme...

VENTANA PD-Ll (SP142) Assay

2022-07-21

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supple...

INFORM HER2 Dual ISH DNA Probe Cocktail

2022-07-21

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS036 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ  Advisory Committee Pathology Supplement Typespecial (immediate Track) Suppleme...

PATHWAY Anti-c-KIT (9.7) Primary Antibody

2022-07-21

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF  Advisory Committee Pathology Supplement Typespecial (immediate Track) Suppleme...

VENTANA HER2 Dual ISH DNA Probe Cocktail

2022-07-21

Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supple...

VENTANA PD-L1(SP142) Assay

2022-06-10

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PLS  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Noti...

CINtec PLUS Cytology

2022-06-10

Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS005 Date Received01/28/2022 Decision Date06/10/2022 Product Code QKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notic...

VENTANA HER2 Dual ISH DNA Probe Cocktail

2022-06-10

Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Noti...

INFORM HER2 Dual ISH DNA Probe Cocktail

2022-06-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS035 Date Received01/28/2022 Decision Date06/10/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice...

PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

2022-06-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS045 Date Received01/28/2022 Decision Date06/10/2022 Product Code MVC  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice...

PATHWAY Anti-c-KIT (9.7) Primary Antibody

2022-06-10

VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS025 Date Received01/28/2022 Decision Date06/10/2022 Product Code NKF  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice...

VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

2022-06-10

Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code QNH  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supp...

VENTANA ALK (D5F3) CDx Assay

2022-06-10

VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PKW  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Noti...

VENTANA PD-L1 (SP263) Assay

2022-06-10

Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS011 Date Received01/28/2022 Decision Date06/10/2022 Product Code PLS  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice...

VENTANA MMR RxDx Panel

2022-05-20

Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS005 Date Received04/28/2022 Decision Date05/20/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT0262...

VENTANA MMR RxDx Panel

2022-03-21

Ventana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS001 Date Received08/18/2021 Decision Date03/21/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT0246...

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