| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2028492 | 1000125183 | VENTANA MEDICAL SYSTEMS, INC. | 1 | N | 2026-01-01 | 1910 EAST INNOVATION PARK DR. Tucson AZ US 85755 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 200901 | 1898816217 | P990081 | PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY | MVC | 2000-11-28 |
| 200901 | 1606018624 | P250031 | VENTANA PTEN (SP218) RxDx Assay | SHF | 2026-06-12 |
| 200901 | 1500327122 | P240037 | VENTANA MET (SP44) RxDx Assay | SER | 2025-05-14 |
| 200901 | 1790705340 | P230018 | VENTANA CLDN18 (43-14A) RxDx Assay | QZJ | 2024-10-18 |
| 200901 | 1671148788 | P220006 | VENTANA FOLR1 (FOLR-2.1) RxDx Assay | QUL | 2022-11-14 |
| 200901 | 1092257352 | P210001 | VENTANA MMR RxDx Panel | QNH | 2021-08-17 |
| 200901 | 1043844839 | P200019 | VENTANA MMR RxDx Panel | QNH | 2021-04-22 |
| 200901 | 1576058275 | P190031 | HER2 Dual ISH DNA Probe Cocktail | NYQ | 2020-07-28 |
| 200901 | 1262145447 | P190024 | CINtec PLUS Cytology | QKF | 2020-03-10 |
| 200901 | 2065010328 | P160046 | VENTANA PD-L1 (SP263) ASSAY | PLS | 2017-05-01 |
| 200901 | 1908079727 | P160006 | VENTANA PD-L1 (SP142) Assay | PLS | 2016-10-18 |
| 200901 | 1824460781 | P160002 | VENTANA PD-L1(SP142) CDX ASSAY | PLS | 2016-05-18 |
| 200901 | 1400256471 | P140025 | VENTANA ALK (D5F3) CDX ASSAY | PKW | 2015-06-12 |
| 200901 | 1002225005 | P100027 | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL | NYQ | 2011-06-14 |
| 200901 | 1942171308 | P020055 | VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY | NKF | 2004-08-11 |
| 200901 | 1897476960 | K242783 | Roche Digital Pathology Dx | PSY | 2024-12-17 |
| 200901 | 1677831841 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | PSY | 2024-06-14 |
| 200901 | 1490143243 | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | OEO | 2015-07-16 |
| 200901 | 1125596642 | K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | NQN | 2014-03-20 |
| 200901 | 1486161181 | K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | NQN | 2013-11-22 |
| 200901 | 1343181147 | K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | NQN | 2013-09-19 |
| 200901 | 1413264070 | K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | NQN | 2013-09-26 |
| 200901 | 2064397781 | K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | NOT | 2012-06-01 |
| 200901 | 1554260012 | K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | NOT | 2013-09-06 |
| 200901 | 1952925473 | K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | NQN | 2012-04-19 |
| 200901 | 2061873219 | K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | NQN | 2012-03-05 |
| 200901 | 1801587429 | K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | NOT | 2012-02-22 |
| 200901 | 1828870196 | K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | NOT | 2011-10-12 |
| 200901 | 1041655433 | K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | MYA | 2012-12-17 |
| 200901 | 1321025057 | K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | MXZ | 2011-11-16 |
| 200901 | 2055265026 | K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | OWF | 2011-08-25 |
| 200901 | 1762811950 | DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | SDP | 2024-12-05 |
| 200901 | 2061651689 | DEN170030 | 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 Primary Antibody | PZJ | 2017-10-27 |
| 200901 | 1503545371 | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | PRB | 2017-03-04 |
| 200901 | 1042066657 | ||||
| 200901 | 1118697313 | ||||
| 200901 | 1496862023 | ||||
| 200901 | 1557491714 | ||||
| 200901 | 1584436848 | ||||
| 200901 | 1733467805 | ||||
| 200901 | 1760444759 | ||||
| 200901 | 2009474986 | ||||
| 200901 | 2030995179 | ||||
| 200901 | 2061129485 | ||||
| 200901 | 1059784457 | ||||
| 200901 | 1102751767 | ||||
| 200901 | 1121524786 | ||||
| 200901 | 1124187555 | ||||
| 200901 | 1170569229 | ||||
| 200901 | 1185703378 | ||||
| 200901 | 1217411149 | ||||
| 200901 | 1272961820 | ||||
| 200901 | 1317542115 | ||||
| 200901 | 1337742726 | ||||
| 200901 | 1342125534 | ||||
| 200901 | 1348781273 | ||||
| 200901 | 1365679858 | ||||
| 200901 | 1367743876 | ||||
| 200901 | 1384732735 | ||||
| 200901 | 1398820130 | ||||
| 200901 | 1401775080 | ||||
| 200901 | 1412904008 | ||||
| 200901 | 1439693033 | ||||
| 200901 | 1443867833 | ||||
| 200901 | 1448197294 | ||||
| 200901 | 1484850392 | ||||
| 200901 | 1486489634 | ||||
| 200901 | 1530137072 | ||||
| 200901 | 1546775874 | ||||
| 200901 | 1603689258 | ||||
| 200901 | 1620659575 | ||||
| 200901 | 1648664374 | ||||
| 200901 | 1667666992 | ||||
| 200901 | 1691612481 | ||||
| 200901 | 1693969989 | ||||
| 200901 | 1698415749 | ||||
| 200901 | 1701543467 | ||||
| 200901 | 1704834194 | ||||
| 200901 | 1714589919 | ||||
| 200901 | 1731976693 | ||||
| 200901 | 1736594003 | ||||
| 200901 | 1739569120 | ||||
| 200901 | 1848037266 | ||||
| 200901 | 1851333679 | ||||
| 200901 | 1915203318 | ||||
| 200901 | 1923906176 | ||||
| 200901 | 1942875281 | ||||
| 200901 | 2065003441 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NQN | 6 | 2014-03-20 |
| NOT | 4 | 2013-09-06 |
| PSY | 2 | 2024-12-17 |
| QNH | 2 | 2021-08-17 |
| PLS | 2 | 2017-05-01 |
| SDP | 1 | 2024-12-05 |
| QUL | 1 | 2022-11-14 |
| NYQ | 1 | 2020-07-28 |
| QKF | 1 | 2020-03-10 |
| PZJ | 1 | 2017-10-27 |
| PRB | 1 | 2017-03-04 |
| PLS | 1 | 2016-10-18 |
| OEO | 1 | 2015-07-16 |
| PKW | 1 | 2015-06-12 |
| MYA | 1 | 2012-12-17 |
| MXZ | 1 | 2011-11-16 |
| OWF | 1 | 2011-08-25 |
| NYQ | 1 | 2011-06-14 |
| NKF | 1 | 2004-08-11 |
| MVC | 1 | 2000-11-28 |
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 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 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...
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...
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...
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 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...
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 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 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 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 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 ...
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...
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...
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 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 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 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 ...
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 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 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 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...
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...
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 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 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...
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...
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 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 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...
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 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...
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...
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...
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 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 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 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 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 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...
Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
Ventana Medical Systems, Inc.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYTEMS, INC
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
VENTANA MEDICAL SYSTEMS, INC.
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