DRI Digoxin Assay

GUDID 00884883011434

Microgenics Corporation

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

• Primary Device ID: 00884883011434
• NIH Device Record Key: 91acfd1a-966f-4d1d-8405-8ea93de74183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI Digoxin Assay
• Version Model Number: 1669-A
• 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	00884883011434 [Primary]

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: 3
• Public Version Date: 2019-06-05
• Device Publish Date: 2016-09-26

On-Brand Devices [DRI Digoxin Assay]

• 00884883011434: 1669-A
• 00884883001206: 1669