CEDIA Multi-Drug OFT Control Set

GUDID 00884883010987

Microgenics Corporation

Multiple drugs of abuse IVD, control

• Primary Device ID: 00884883010987
• NIH Device Record Key: 0855ab33-767a-44f3-b553-1744f93b147f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Multi-Drug OFT Control Set
• Version Model Number: 10014957
• 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	00884883010987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101752

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: 2016-09-22

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• 07613336190791 - OXY DRI Oxycodone: 2021-11-03
• 00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays: 2021-05-13
• 00884883007765 - MAS SARS-CoV-2 IgG Positive Control: 2021-03-15
• 00884883007772 - MAS SARS-CoV-2 Negative Control: 2021-03-15