CEDIA AntibioticTDM Multi-Calibrator

GUDID 00884883001329

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00884883001329
• NIH Device Record Key: 548a8863-41d4-4990-a199-d0666d279350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA AntibioticTDM Multi-Calibrator
• Version Model Number: 100017
• 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	00884883001329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963191

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

Devices Manufactured by Microgenics Corporation

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• 00884883009356 - MAS Omni•IMMUNE PRO Max, Level 2: 2025-08-20
• 00884883009363 - MAS Omni•IMMUNE PRO Max, Level 3: 2025-08-20
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