Optilite C4 Kit

Basic Information

• Brand Name: Optilite C4 Kit
• Primary DI: 05051700017602
• Version / Model: NK025.OPT.A
• 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: 3a161f7e-2a5f-4727-ba34-d4968ee1ffa4

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
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	866.5240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53691	Complement components C4/C4c IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700017602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100455	000

Storage Conditions

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