ANA Test Kit 15-113

GUDID 10862534000317

Antinuclear Antibody (ANA) Test Kit

ANTIBODIES INCORPORATED

Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 10862534000317
• NIH Device Record Key: 0b752f52-e905-4b24-9497-31a17ad6ade0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA Test Kit
• Version Model Number: 15-113
• Catalog Number: 15-113
• Company DUNS: 048944128
• Company Name: ANTIBODIES INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10862534000317 [Primary]

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-02-09
• Device Publish Date: 2016-12-20

On-Brand Devices [ANA Test Kit ]

• 10862534000324: Antinuclear Antibody (ANA) Test Kit
• 10862534000317: Antinuclear Antibody (ANA) Test Kit
• 10862534000300: Antinuclear Antibody (ANA) Test Kit