CEDIA Digitoxin Assay

GUDID 00884883005648

Microgenics Corporation

Digitoxin therapeutic drug monitoring IVD, kit, fluorescent immunoassay

• Primary Device ID: 00884883005648
• NIH Device Record Key: 67d0f2d5-09c5-464b-b3ad-4b776b9e19b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Digitoxin Assay
• Version Model Number: 100004
• 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	00884883005648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896021

FDA Product Code

• LFM: Enzyme Immunoassay, Digitoxin

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: 2016-09-12

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