Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System

Basic Information

• Brand Name: Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System
• Primary DI: B110AN10120
• Version / Model: AN-1012
• Catalog Number: AN-1012
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: 286489a9-9255-4df8-a581-e37ad00c4bf2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54811	Multiple antinuclear antibody (ANA) screening IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110AN10120	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K872845	000

Storage Conditions

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