VENTANA PD-L1 (SP263) Assay
Ventana Medical Systems, Inc.
VENTANA MEDICAL SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2028492 | 1000125183 | VENTANA MEDICAL SYSTEMS, INC. | 1 | N | 2027-01-01 | 1910 EAST INNOVATION PARK DR. Tucson AZ US 85755 |
Registered Device Listings#
| 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 Codes Associated With Registrations#
| 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 |
PMA#
VENTANA PD-L1 (SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
PATI-IWAY Anti-c-KIT (9.7) Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-LI (SP263) Assay
Ventana Medical Systems, Inc.
VENTANA HER2 Dual ISI-I DNA Probe Cocktail
Ventana Medical Systems, Inc.
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-LI (SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
CINtec PLUS Cytology
Ventana Medical Systems, Inc.
VENTANA ALK (D5F3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
CINtec PLUS Cytology
Ventana Medical Systems, Inc.
VENTANA PD-L1 (SP263) Assay
Ventana Medical Systems, Inc.
INFORM HER2 Dual ISH DNA Probe Cocktail
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1 (SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
VENTANA HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc.
PATHWAY Anti-c-KIT (9.7) Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
CINtec PLUS Cytology
Ventana Medical Systems, Inc.
HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc.
Ventana PD-L1 (SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-c-KIT (9.7) Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ALK (D5F3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1 (SP263) Assay
Ventana Medical Systems, Inc.
VENTANA PD-L1(SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
CINtec PLUS Cytology
Ventana Medical Systems, Inc.
Inform HER2 Dual ISH DNA Probe Cocktail
VENTANA MEDICAL SYSTEMS, INC.
Ventana PD-Ll (SP142) Assay
VENTANA MEDICAL SYSTEMS, INC.
Ventana ALK (D5F3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
Ventana PD-Ll (SP263) Assay
Ventana Medical Systems, Inc.
PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
INFORM HER2 Dual ISH DNA Probe Cocktail assays
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PD-L1(SP142) Assay.
VENTANA MEDICAL SYSTEMS, INC.
Ventana ALK (D5f3) CDx Assay
VENTANA MEDICAL SYSTEMS, INC.
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
VENTANA MEDICAL SYSTEMS, INC.
PMN#
Roche Digital Pathology Dx
Ventana Medical Systems, Inc.
Roche Digital Pathology Dx (VENTANA DP 200)
Ventana Medical Systems, Inc.
CINtec Histology
Ventana Medical Systems, Inc.
VENTANA CD30 (Ber-H2) RxDx Assay
Ventana Medical Systems, Inc.
Virtuoso System For IHC PR (1E2) Using IScan HT
Ventana Medical Systems, Inc.
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC ER (SPI)
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC.
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VIRTUSO SYSTEM FOR IHC (DO-7)
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
Ventana Medical Systems, Inc.
VIRTUOSO SYSTEM FOR IHC PR (IE2)
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC.
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
VENTANA MEDICAL SYSTEMS, INC.
VENTANA CD45 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
VENTANA MEDICAL SYSTEMS, INC.
CHEMMATE LAMBDA
VENTANA MEDICAL SYSTEMS, INC.
CHEMMATE L26 (CD20)
VENTANA MEDICAL SYSTEMS, INC.
CHEMMATE KAPPA
VENTANA MEDICAL SYSTEMS, INC.
CHEMMATE LCA
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-S100 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-CD8 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-CD4 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
ANTI-VIMENTIN PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA CEA PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA ANTI-CD5 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANNA ANTI-CD3 PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
KERATIN PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
ANTI-KERATIN-HMW PRIMARY ANTI-BODY
VENTANA MEDICAL SYSTEMS, INC.
KERATIN PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA BLUE DETECTION KIT
VENTANA MEDICAL SYSTEMS, INC.
VENTANA EMA PRIMARY ANDIBODY
VENTANA MEDICAL SYSTEMS, INC.
VENTANA NEGATIVE CONTROL REAGENT
VENTANA MEDICAL SYSTEMS, INC.
GUDID#
ISH Peroxidase Inhibitor - 07729014001
2026-07-13
VENTANA MTAP (SP530) Rabbit Monoclonal Antibody - 10574518001
2026-06-08
VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody - 10496410001
2026-05-18
Congo Red Stain Core Kit - 10585021001
2026-04-10
Gram Stain Core Kit - 10608358001
2026-04-10
SSR Solution - 06890059001
2021-02-03
VENTANA® U6 DIG Probe - 10062746001
2026-03-26
ASSY RGT DSPNR CARD BMK PREP KIT 301 - 10637412001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 302 - 10637439001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 303 - 10637447001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 304 - 10637455001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 305 - 10637463001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 306 - 10637471001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 307 - 10637480001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 308 - 10637498001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 309 - 10637501001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 310 - 10637536001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 311 - 10637544001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 312 - 10637552001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 313 - 10637579001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 314 - 10637587001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 315 - 10637595001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 316 - 10637609001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 317 - 10637617001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 318 - 10637625001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 319 - 10637633001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 320 - 10637641001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 321 - 10637650001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 322 - 10637668001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 323 - 10637676001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 324 - 10637684001
2026-03-20
ASSY RGT DSPNR CARD BMK PREP KIT 325 - 10637692001
2026-03-20
VENTANA pan-TRK (EPR17341) Assay - 09365583001
2026-03-16
VENTANA PD-L1 (SP263) Assay - 50 test
2017-09-26
PAX-8 (SP348) Rabbit Monoclonal Antibody - 10272589001
2026-02-16
Antibody Diluent - 05261899001
2025-12-15
Bluing Reagent - 05266769001
2025-12-15
Amplification Kit - 05266114001
2025-12-15
Alcian Blue Staining Kit - 05279186001
2025-12-15
Alcian Blue for PAS - 05279194001
2025-12-15