OncoMate MSI Dx Interpretive Software MD4140

GUDID 00849811056857

Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.

PROMEGA CORPORATION

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

• Primary Device ID: 00849811056857
• NIH Device Record Key: 887f41bc-636d-4410-a0c8-eaea0fab0071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OncoMate MSI Dx Interpretive Software
• Version Model Number: MD4140
• Catalog Number: MD4140
• 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	00849811056857 [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

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• 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