COVID-19 Detect™ Rapid Self -Test

GUDID B379C19S21

INBIOS INTERNATIONAL, INC

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

• Primary Device ID: B379C19S21
• NIH Device Record Key: 9a802999-c2aa-4a8e-81c9-4373c601fecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVID-19 Detect™ Rapid Self -Test
• Version Model Number: C19S-2
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B379C19S21 [Primary]

FDA Product Code

• QYT: Over-The-Counter Covid-19 Antigen Test

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: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by INBIOS INTERNATIONAL, INC

• B379C19S21 - COVID-19 Detect™ Rapid Self -Test: 2026-01-26
• B379C19S21 - COVID-19 Detect™ Rapid Self -Test: 2026-01-26
• B379COVAF201 - SCoV-2 Ag Detect™ Rapid Test: 2024-09-23 POC COVID-19 antigen test, 20 tests/kit
• B379COVAF501 - SCoV-2 Ag Detect™ Rapid Test: 2024-09-23 POC COVID-19 antigen test, 50tests/kit
• B379STNG11 - Strongy DetectTM IgG ELISA: 2024-09-23
• B379AAP11 - Active Anthrax Detect Plus Rapid Test: 2023-03-13
• B379COV2E0 - Smart DetectTM SARS-CoV-2 rRT-PCR Kit: 2020-07-23 EUA
• B379ZKM21 - ZIKV Detect™ 2.0 IgM Capture ELISA: 2019-06-03
• B379CL0251 - CL Detect Rapid Test for Cutaneous Leishmaniasis: 2018-10-25