BioCheck T4 EIA Test Kit BC-1007

GUDID 00850392007077

The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum.

BIOCHECK, INC.

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850392007077
• NIH Device Record Key: a26e80a7-2ec2-413d-9e12-d9a7c0b661c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCheck T4 EIA Test Kit
• Version Model Number: BC-1007
• Catalog Number: BC-1007
• Company DUNS: 171857493
• Company Name: BIOCHECK, INC.
• 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: 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

Customer Support Contacts

• Phone: (650)573-1968
• Email: info@biocheckinc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392007077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991432

FDA Product Code

• KLI: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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: 2019-10-16
• Device Publish Date: 2019-10-08

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