KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Basic Information

• Brand Name: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
• Primary DI: B126KR77550
• Version / Model: KR7755
• Catalog Number: KR7755
• Company Name: KRONUS, INC.
• Labeler DUNS: 181070814
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-22
• Public Version: 3
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: b6397fbe-6c83-4e36-b7d5-80f0ce8fa373

Device Description

An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55214	Thyrosin phosphatase antibody (anti-IA2) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyrosin phosphatase (anti-IA2) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B126KR77550	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171731	000
K220085	000