IFA ANA Rat Liver Tissue Test System

Basic Information

• Brand Name: IFA ANA Rat Liver Tissue Test System
• Primary DI: 00845533001359
• Version / Model: FA2001
• Catalog Number: FA2001
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8b340e46-8075-4c17-9880-d11a32eadb4e

Device Description

The ZEUS IFA ANA Rat Liver Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

Device Characteristics

• Single Use: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
54851	Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen, using an fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533001359	GS1

Storage Conditions

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