OncoMate MSI Dx Interpretive Software MD4140

GUDID 00849811056857

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

PROMEGA CORPORATION

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• 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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