Zinc Transporter 8 Auto-Antibody (ZnT8) KR7730

GUDID B126KR77300

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.

KRONUS, INC.

Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B126KR77300
• NIH Device Record Key: 86d3c5a8-4ffe-4151-84e5-41c9f382fc91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zinc Transporter 8 Auto-Antibody (ZnT8)
• Version Model Number: KR7730
• Catalog Number: KR7730
• Company DUNS: 181070814
• Company Name: KRONUS, 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: 800-457-6687
• Email: kronus@kronus.com
• Phone: 800-457-6687
• Email: kronus@kronus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B126KR77300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140001

FDA Product Code

• PHF: Zinc Transporter 8 Auto-Antibody

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: 2016-09-23

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