DRI Digoxin Assay

GUDID 00884883001206

Microgenics Corporation

Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00884883001206
• NIH Device Record Key: 4f5e1bf0-d179-4a36-a0a3-259169517e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Digoxin Assay
• Version Model Number: 1669
• 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	00884883001206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983323

FDA Product Code

• DLJ: Calibrators, Drug Specific
• KXT: Enzyme Immunoassay, Digoxin

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: 2019-06-05
• Device Publish Date: 2016-09-12

On-Brand Devices [DRI Digoxin Assay]

• 00884883011434: 1669-A
• 00884883001206: 1669