CEDIA Opiate OFT Assay

GUDID 00884883000247

Microgenics Corporation

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883000247
• NIH Device Record Key: a526b6d6-6cd2-4250-bbd7-0ca2dd79c49b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Opiate OFT Assay
• Version Model Number: 10018600
• Company DUNS: 122153799
• Company Name: Microgenics 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: 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	00884883000247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101754

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: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [CEDIA Opiate OFT Assay]

• 00884883011113: 10014873
• 00884883000810: 10021778
• 00884883000247: 10018600