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Bio-Self COVID-19 Antigen Home Test

FDA UDI

Class N (US FDA UDI)

by Bioteke Usa Llc

Identity

Trade Name
Bio-Self COVID-19 Antigen Home Test FDA UDI
Generic Name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box) FDA UDI
Model / Reference
BTK-H2202 FDA UDI
Description
COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box) FDA UDI

Identifiers

Primary DI / UDI-DI
00860013635114 FDA UDI
FDA Product Code
QKP FDA UDI
GMDN Term
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Bio-Self COVID-19 Antigen Home Test by Bioteke Usa Llc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioteke Usa Llc

Sources (1)

  • FDA UDI 9a3a42c6-e5cb-4102-b5ab-ce7029bd5ca7 33 fields · synced Jun 6, 2026