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OncoMate MSI Dx Interpretive Software

Primary DI
00849811056857
Brand
OncoMate MSI Dx Interpretive Software
Company
PROMEGA CORPORATION
Model
MD4140
Catalog number
MD4140
Device description
Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.
Published
2021-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PZJLynch Syndrome Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZJLynch Syndrome Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200129000OncoMate MSI Dx Analysis SystemPromega Corporation2021-07-26PZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811056857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811056857008498110568578498110568570849811056857

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849811081835Maxwell® CSC Rapid ccfDNA KitAS1580AS15802026-02-16
00849811083457OncoMate® MSI Dx Analysis SoftwareMD4160MD41602026-02-16
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
00849811056864OncoMate MSI Dx Assay InstallerMD4150MD41502021-10-08
00849811004445Abbott mSample Preparation System04J70-2404J70-242017-08-25
00849811004452Abbott mSample Preparation System DNA06K12-2406K12-242017-08-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055331336019BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
00849811056864OncoMate MSI Dx Assay InstallerPROMEGA CORPORATIONPZJ2021-10-08
00849811031717OncoMate MSI Dx Analysis SystemPROMEGA CORPORATIONPZJ2021-09-30
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONPZJ2021-09-30
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