CEDIA Amphetamine OFT Assay

GUDID 00884883000841

Microgenics Corporation

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883000841
• NIH Device Record Key: 6fcc2acb-27ad-4123-805f-2c83b8cfc9c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Amphetamine OFT Assay
• Version Model Number: 10021729
• 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	00884883000841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101745

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2016-10-03

On-Brand Devices [CEDIA Amphetamine OFT Assay]

• 00884883011069: 10014947
• 00884883000841: 10021729
• 00884883000209: 10018579