DRI T-Uptake

GUDID 00884883003453

Microgenics Corporation

Thyroid uptake (T-uptake) IVD, kit, fluorescent immunoassay

• Primary Device ID: 00884883003453
• NIH Device Record Key: c51a818e-1805-469a-9886-c88b5d2de11f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRI T-Uptake
• Version Model Number: 0723
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00884883003453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951586

FDA Product Code

• KHQ: Radioassay, Triiodothyronine Uptake

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: 2019-07-09
• Device Publish Date: 2016-10-03

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