Acetylcholine Receptor Autoantibodies (ARAb) RRA

Basic Information

• Brand Name: Acetylcholine Receptor Autoantibodies (ARAb) RRA
• Primary DI: 04049325001428
• Version / Model: RE21023
• Catalog Number: RE21023
• Company Name: IBL International GmbH
• Labeler DUNS: 312694785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 60856917-d15a-4f54-af0d-0a2d1d9d5859

Device Description

Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 30 determinations

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
NST	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62261	Acetylcholine receptor antibody IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to acetylcholine receptor in a clinical specimen, using a radioimmunoassay method. It is typically used in the differential diagnosis of Myasthenia gravis (MG).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049325001428	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius