Acetylcholine Receptor Autoantibodies (ARAb) RRA RE21023

GUDID 04049325001428

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

IBL International GmbH

Acetylcholine receptor antibody IVD, kit, radioimmunoassay

• Primary Device ID: 04049325001428
• NIH Device Record Key: 60856917-d15a-4f54-af0d-0a2d1d9d5859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetylcholine Receptor Autoantibodies (ARAb) RRA
• Version Model Number: RE21023
• Catalog Number: RE21023
• Company DUNS: 312694785
• Company Name: IBL International GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49405328910
• Email: IBL@Tecan.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049325001428 [Primary]

FDA Product Code

• NST: Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

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: 2016-09-24

On-Brand Devices [Acetylcholine Receptor Autoantibodies (ARAb) RRA]

• 04049325001428: Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 30 determinations
• 04049325001404: Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations