OncoMate 5C Matrix Standard MD4850

GUDID 00849811050619

Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System.

PROMEGA CORPORATION

Microsatellite instability IVD, reagent

• Primary Device ID: 00849811050619
• NIH Device Record Key: 3bc0f50a-e636-4542-8177-cdc02a8a1b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OncoMate 5C Matrix Standard
• Version Model Number: MD4850
• Catalog Number: MD4850
• Company DUNS: 089855696
• Company Name: PROMEGA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849811050619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200129

FDA Product Code

• PZJ: Lynch Syndrome Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

Devices Manufactured by PROMEGA CORPORATION

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• 00849811083457 - OncoMate® MSI Dx Analysis Software: 2026-02-24 Software used to analyze data obtained using the OncoMate® MSI Dx Analysis System
• 00849811083778 - Maxwell® CSC XtractAll FFPE DNA/RNA Kit: 2026-02-24 The Maxwell® CSC XtractAll FFPE DNA/RNA Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform auto
• 00849811089114 - OncoMate® MSI Dx Assay Installer: 2026-02-24 Software for installing OncoMate® MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer
• 00849811075902 - QuantiFluor® Dx dsDNA System: 2023-08-23 The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample c
• 00849811066115 - Maxwell® CSC Genomic DNA Kit: 2023-06-20 The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isola
• 00849811069062 - Maxwell® CSC Pathogen Total Nucleic Acid Kit: 2023-06-20 The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to per
• 00849811051340 - Maxwell® CSC Instrument: 2022-02-09 The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perf