Bio-Self COVID-19 Antigen Home Test

GUDID 00197644380435

COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)

BIOTEKE USA, LLC

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

• Primary Device ID: 00197644380435
• NIH Device Record Key: 1627fa98-bc49-4240-a832-aafc0f6ec73e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Self COVID-19 Antigen Home Test
• Version Model Number: BTK-H2202
• Company DUNS: 111149202
• Company Name: BIOTEKE USA, LLC
• 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: true
• Manufacturing Date: true
• 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
GS1	00197644380435 [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: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [Bio-Self COVID-19 Antigen Home Test]

• 00197644563371: COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
• 00197644380435: COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)
• 00197644204359: COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)