Advin COVID-19 Antigen Test @Home

GUDID B115ABCASS1CANAO25T1

ADVIN BIOTECH, INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: B115ABCASS1CANAO25T1
• NIH Device Record Key: fdfc1760-2b29-4a2b-b4da-58fdbd46b2c3
• Commercial Distribution Discontinuation: 2080-12-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advin COVID-19 Antigen Test @Home
• Version Model Number: ABCASS(1)-CAN-AO-25T
• Company DUNS: 006463333
• Company Name: ADVIN BIOTECH, INC.
• 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: false
• 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
HIBCC	B115ABCASS1CANAO25T1 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-06
• Device Publish Date: 2025-12-29

On-Brand Devices [Advin COVID-19 Antigen Test @Home]

• B115ABCASS1CANAO1: ABCass(1)-CAN-AO
• B115ABCASS1CANAO25T1: ABCASS(1)-CAN-AO-25T