ImmunoWELL Thyroglobulin IgG Quantitative Test 3030

GUDID 00613745030302

The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders.

Genbio

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00613745030302
• NIH Device Record Key: 1d85cebd-2c7a-4e49-9920-aae352617e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoWELL Thyroglobulin IgG Quantitative Test
• Version Model Number: 800-3030
• Catalog Number: 3030
• Company DUNS: 940425333
• Company Name: Genbio
• 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: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745030302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905485

FDA Product Code

• JNL: Immunochemical, Thyroglobulin Autoantibody

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: 2016-09-24

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