Advin COVID-19 Antigen Test @Home

GUDID B115ABCASS1CANAO1

ADVIN BIOTECH, INC.

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

• Primary Device ID: B115ABCASS1CANAO1
• NIH Device Record Key: 1a9e288f-9d56-4efa-9958-60e715e0542d
• Commercial Distribution Discontinuation: 2080-01-20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advin COVID-19 Antigen Test @Home
• Version Model Number: ABCass(1)-CAN-AO
• 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	B115ABCASS1CANAO1 [Primary]
HIBCC	B115ABCASS1CANAO2 [Package]; Package: [25 Units]; Discontinued: 2080-01-20; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-28
• Device Publish Date: 2023-01-20

Devices Manufactured by ADVIN BIOTECH, INC.

• 10840050517519 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-09-05 AMP500/BZO300/COC150/MET500/OPI300/THC50
• B115ABCASS1CANAO1 - Advin COVID-19 Antigen Test @Home: 2024-08-28
• B115ABCASS1CANAO1 - Advin COVID-19 Antigen Test @Home: 2024-08-28
• 10840050517496 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• 10840050517526 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
• 00840050517536 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
• B115SECARD01THC500 - Sienna Multi-Drug Test Dip Card: 2022-10-28 THC50
• B115SECARD05090 - Sienna Multi-Drug Test Dip Card: 2022-10-28 AMP500/COC150/OPI2000/PCP25/THC50
• B115SECARD06100 - Sienna Multi-Drug Test Dip Card: 2022-10-28 AMP500/BZO300/COC150/MET500/OPI2000/THC50