CEDIA Bupernorphine II Assay

GUDID 00884883004757

Microgenics Corporation

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883004757
• NIH Device Record Key: 13016b6d-5490-45bd-abcc-9a23a7363bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Bupernorphine II Assay
• Version Model Number: 10020850
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883004757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163101

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: 2017-05-12

On-Brand Devices [CEDIA Bupernorphine II Assay]

• 00884883004757: 10020850
• 00884883003873: 10020849