FDA.reportPublic FDA data

MSH2 IHC pharmDx (Dako Omnis)

Primary DI
05700575005220
Brand
MSH2 IHC pharmDx (Dako Omnis)
Company
AGILENT TECHNOLOGIES, INC.
Model
GE085
Device description
MSH2 IHC pharmDx (Dako Omnis)
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNHImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250004000MMR IHC Panel pharmDx (Dako Omnis)Agilent Technologies, Inc.2025-08-15QNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700575005220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700575005220057005750052205700575005220

GMDN Terms#

Term, Definition table
TermDefinition
MSH2 antigen IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of MSH2 antigen in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags#

DUNS number
084963177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700575016899PD-L1 Control SlidesT13912026-04-29
05700573001736PD-L1 Control SlidesT13912020-11-17
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1M36752026-01-21
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636M35692016-09-16
05700571107713DakoGC2062024-08-07
05700575005213MLH1 IHC pharmDx (Dako Omnis)GE0792025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)GE0862025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)GE0872025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)GE1022025-08-27
05700571102022Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3M35012020-09-17
05700571102053Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10M35042020-09-17
05700571102190Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1M35392020-09-17
05700571102503Mono Mo A-Hu Tyrosinase Cl T311M36232020-09-17
05700571101933Mono Mo A-Thrombomodulin Cl 1009M06172020-09-17
05700571102039Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93M35022020-09-17
05700571101995Mono Mo A-Hu Muscle Actin Cl HHF35M06352020-09-17
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294M35682016-09-16
05700571102046Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042M35032020-09-17
05700571102091Mono Mo A-MyoD1 Cl 5.8AM35122020-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700575005213MLH1 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
07613336100561VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100578VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100585VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08
07613336100592VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.QNH2018-02-08