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BinaxNOW COVID-19 Antigen Self Test

FDA UDI

Class N (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
BinaxNOW COVID-19 Antigen Self Test FDA UDI
Generic Name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. FDA UDI
Model / Reference
195-268 FDA UDI
Description
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. FDA UDI

Identifiers

Primary DI / UDI-DI
00811877011705 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

BinaxNOW COVID-19 Antigen Self Test by Alere Scarborough, Inc. — 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
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 08ee1404-40b0-498e-ac91-3890535d9068 33 fields · synced May 31, 2026