KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT KR6755

GUDID B126KR67550

A radioimmunoassay for the semi-quantitative determination of antibodies to tyrosine phosphatase (IA-2) in human serum.

KRONUS, INC.

Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay

• Primary Device ID: B126KR67550
• NIH Device Record Key: b1f9d9ea-2cf4-47eb-806e-888d97fea056
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
• Version Model Number: KR6755
• Catalog Number: KR6755
• 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	B126KR67550 [Primary]

FDA Product Code

• OIF: Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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