DRI Opiate Urine Calibrator 3

GUDID 00884883005303

Microgenics Corporation

Opiate/opiate metabolite IVD, calibrator

• Primary Device ID: 00884883005303
• NIH Device Record Key: 97bffe8b-9384-4c2f-a7ab-861d74d338e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Opiate Urine Calibrator 3
• Version Model Number: 1610
• 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	00884883005303 [Primary]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-04
• Device Publish Date: 2016-09-12

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