SCoV-2 Ag Detect™ Rapid Test

GUDID B379COVAF201

POC COVID-19 antigen test, 20 tests/kit

INBIOS INTERNATIONAL, INC

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: B379COVAF201
• NIH Device Record Key: 46cb59e9-24be-427c-bb46-afa3b6ed18e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCoV-2 Ag Detect™ Rapid Test
• Version Model Number: COVAF-20
• Company DUNS: 004006628
• Company Name: INBIOS INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B379COVAF201 [Primary]

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: 2024-09-23
• Device Publish Date: 2024-09-13

On-Brand Devices [SCoV-2 Ag Detect™ Rapid Test]

• B379COVAF501: POC COVID-19 antigen test, 50tests/kit
• B379COVAF201: POC COVID-19 antigen test, 20 tests/kit