C-3 Proactivator RID plate package

Basic Information

• Brand Name: C-3 Proactivator RID plate package
• Primary DI: B1761064
• Version / Model: 1
• Catalog Number: 106411
• Company Name: KENT LABORATORIES INC
• Labeler DUNS: 093642254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 78a2a5ab-9c7b-40b9-a3a6-f515620a72c4

Device Description

Radial immunodiffusion plate package for Human C-3 Proactivator (factor B)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
JZQ	Plates And Equipment, Radial Immunodiffusion	Immunology	866.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62013	Complement factor B IVD, kit precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of complement factor B of the alternative pathway in a clinical specimen, using a precipitation/immunodiffusion method. Elevated levels of complement factor B are associated with infection and trauma.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1761064	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 8 Degrees Celsius