Access Free T3 A13422

GUDID 15099590201661

The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590201661
• NIH Device Record Key: b64fb8e4-a1c5-4737-95b2-d1432e18e0ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Free T3
• Version Model Number: A13422
• Catalog Number: A13422
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590201661 [Primary]

FDA Product Code

• CDP: Radioimmunoassay, Total Triiodothyronine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

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