VIDAS® T3

GUDID 03573026156909

The VIDAS ® T3 (T3) assay is intended for use on the VIDAS instruments for the quantitative determination of triiodothyronine (T3) concentration in serum or plasma (heparin).

BIOMERIEUX SA

Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026156909
• NIH Device Record Key: 6dbf76c6-053a-451c-90c7-f8b4c789a9e7
• Commercial Distribution Discontinuation: 2017-12-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIDAS® T3
• Version Model Number: 30403-01
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026156909 [Primary]

FDA Product Code

• CDP: Radioimmunoassay, Total Triiodothyronine

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: 2020-05-14
• Device Publish Date: 2016-08-31

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