Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit

Basic Information

• Brand Name: Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit
• Primary DI: 05051700010375
• Version / Model: RK015
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 37279c1f-5e81-472c-848c-ec0adcdc187a
• Distribution End Date: 2023-05-31

Device Characteristics

• Single Use: No
• 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
CZP	Iga, Antigen, Antiserum, Control	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61985	Immunoglobulin A subclass (IgA subclass) IVD, kit, precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen, using a precipitation/immunodiffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700010375	GS1

Customer Contacts

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

Storage Conditions

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