DRI Serum Tox Negative Calibrator

GUDID 00884883001091

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00884883001091
• NIH Device Record Key: 50ecf59d-bd8b-4fd5-b6da-ecf52e29635b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Serum Tox Negative Calibrator
• Version Model Number: 0962
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	00884883001091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961372

FDA Product Code

• DKB: Calibrators, Drug Mixture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-04
• Device Publish Date: 2016-09-12

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