Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit

Basic Information

• Brand Name: Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit
• Primary DI: 05051700010504
• Version / Model: RN019.3
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d5dd3d0a-1369-41fa-8233-2324ecac734a

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
DBA	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	Immunology	866.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62030	Complement component C1 inhibitor IVD, kit, precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1 inhibitor in a clinical specimen, using a precipitation/immunodiffusion method. It is used to assess C1 inhibitor activity which is associated with hereditary angioneurotic oedma.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700010504	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K915431	000

Storage Conditions

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