IgG Anti-nDNA Fluorescent Test System

Basic Information

• Brand Name: IgG Anti-nDNA Fluorescent Test System
• Primary DI: M7493002G1
• Version / Model: 3002G
• Catalog Number: 3002G
• Company Name: IMMUNO CONCEPTS INC
• Labeler DUNS: 038271904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-28
• Public Version: 2
• Public Version Date: 2019-11-13
• Public Version Status: Update
• Public Device Record Key: 10e5845d-5638-4e9e-98be-bbe697d21099

Device Description

nDNA IgG Fluorescent Bulk Pack - 1400 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
55045	Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7493002G1	HIBCC