ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests

Basic Information

• Brand Name: ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests
• Primary DI: M749100420111
• Version / Model: 100420-11
• Catalog Number: 100420-11
• Company Name: IMMUNO CONCEPTS INC
• Labeler DUNS: 038271904
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-05
• Public Version: 1
• Public Version Date: 2022-01-13
• Public Version Status: New
• Public Device Record Key: 200d330b-8cd3-431b-8dec-9e33659268d3
• Distribution End Date: 2022-01-05

Device Description

ANCA BP FA Test System - Ethanol Fixed Substrate - 420 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
55061	Multiple anti-neutrophil cytoplasmic antibody (ANCA) 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 anti-neutrophil cytoplasmic antibodies (ANCA) 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	M749100420111	HIBCC