OncoMate MSI Dx Assay Installer MD4150

GUDID 00849811056864

Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer

PROMEGA CORPORATION

Microsatellite instability IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00849811056864
• NIH Device Record Key: 5c4b2d07-91a9-4338-9d0e-957a796475bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OncoMate MSI Dx Assay Installer
• Version Model Number: MD4150
• Catalog Number: MD4150
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00849811056864 [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: 2021-10-18
• Device Publish Date: 2021-10-08

Devices Manufactured by PROMEGA CORPORATION

• 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
• 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
• 00849811051746 - Maxwell® CSC RNA FFPE Kit: 2022-02-09 The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
• 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