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 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

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• 00849811051739 - Maxwell® CSC RNA Blood Kit: 2022-02-09 The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati
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• 00849811051753 - Maxwell® CSC DNA FFPE Kit: 2022-02-09 The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
• 00849811051777 - Maxwell® CSC Blood DNA Kit: 2022-02-09 The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati