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OncoMate® MSI Dx Analysis Software

Primary DI
00849811083457
Brand
OncoMate® MSI Dx Analysis Software
Company
PROMEGA CORPORATION
Model
MD4160
Catalog number
MD4160
Device description
Software used to analyze data obtained using the OncoMate® MSI Dx Analysis System
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SFLNucleic Acid Based Assay, Microsatellite Instability

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFLNucleic Acid Based Assay, Microsatellite InstabilityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240026000OncoMate® MSI Dx Analysis SystemPromega Corporation2025-11-05SFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811083457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811083457008498110834578498110834570849811083457

GMDN Terms#

Term, Definition table
TermDefinition
Microsatellite instability IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089855696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849811081835Maxwell® CSC Rapid ccfDNA KitAS1580AS15802026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitAS1560AS15602026-02-16
00849811089114OncoMate® MSI Dx Assay InstallerMD4130MD41302026-02-16
00849811031717OncoMate MSI Dx Analysis SystemMD2140MD21402021-09-30
00849811050619OncoMate 5C Matrix StandardMD4850MD48502021-09-30
00849811066115Maxwell® CSC Genomic DNA KitAS1850AS18502023-06-12
00849811060960Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780AS17802022-02-01
00849811064647Maxwell® CSC Whole Blood DNA KitAS1820AS18202022-02-01
00849811069062Maxwell® CSC Pathogen Total Nucleic Acid Kit AS1860AS18602023-06-12
00849811051340Maxwell® CSC InstrumentAS6000AS60002022-02-01
00849811060991Maxwell® CSC 48 InstrumentAS8000AS80002022-02-01
00849811075902QuantiFluor® Dx dsDNA SystemE5900E59002023-08-15
00849811051739Maxwell® CSC RNA Blood KitAS1410AS14102022-02-01
00849811051746Maxwell® CSC RNA FFPE KitAS1360AS13602022-02-01
00849811051753Maxwell® CSC DNA FFPE KitAS1350AS13502022-02-01
00849811051777Maxwell® CSC Blood DNA KitAS1321AS13212022-02-01
00849811056857OncoMate MSI Dx Interpretive SoftwareMD4140MD41402021-10-08
00849811056864OncoMate MSI Dx Assay InstallerMD4150MD41502021-10-08
00849811004445Abbott mSample Preparation System04J70-2404J70-242017-08-25
00849811004452Abbott mSample Preparation System DNA06K12-2406K12-242017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849811089114OncoMate® MSI Dx Assay InstallerPROMEGA CORPORATIONSFL2026-02-16
15415219001328Idylla CDx MSI TestBiocartis NVSFL2025-11-01
00849811031717OncoMate MSI Dx Analysis SystemPROMEGA CORPORATIONSFL2021-09-30
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONSFL2021-09-30