FDA.reportPublic FDA data

VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody

Primary DI
07613336100561
Brand
VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody
Company
Ventana Medical Systems, Inc.
Model
790-5091
Catalog number
07862237001
Device description
MMR IHC Panel Antibody
Published
2018-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZJLynch Syndrome Test System
QNHImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZJLynch Syndrome Test SystemImmunology2
QNHImmunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein AssayHematology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170030000
P200019000
P210001000
P210001001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170030000VENTANA 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 AntibodyVentana Medical Systems2017-10-27PZJ
P200019000VENTANA MMR RxDx PanelVentana Medical Systems2021-04-22QNH
P210001000VENTANA MMR RxDx PanelVentana Medical Systems, Inc. (Roche Tissue Diagnostics)2021-08-17QNH
P210001001VENTANA MMR RxDx PanelVentana Medical Systems, Inc. (Roche Tissue Diagnostics)2021-08-17QNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336100561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336100561076133361005617613336100561

GMDN Terms#

Term, Definition table
TermDefinition
Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict hereditary nonpolyposis colon cancer (HNPCC) associated with mutations in one of several genes that are important in the detection and repair ofdeoxyribonucleic acid (DNA) base-pair mismatches, which may include MLH1, MSH2, MLH3, MSH6, PMS1 and PMS2.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700575005213MLH1 IHC pharmDx (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
05700575005220MSH2 IHC pharmDx (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)AGILENT TECHNOLOGIES, INC.QNH2025-08-27
15415219000758Idylla™ MSI TestBiocartis NVPZJ2023-05-03
05055331335906BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331335920BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336002BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336019BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
00849811056857OncoMate MSI Dx Interpretive SoftwarePROMEGA CORPORATIONPZJ2021-10-08
00849811056864OncoMate MSI Dx Assay InstallerPROMEGA CORPORATIONPZJ2021-10-08
00849811031717OncoMate MSI Dx Analysis SystemPROMEGA CORPORATIONPZJ2021-09-30
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONPZJ2021-09-30
07613336100578VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100578VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100585VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100585VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100592VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100592VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100608VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08