FDA.reportPublic FDA data

BinaxNOW COVID-19 Antigen Self Test

Primary DI
00811877011118
Brand
BinaxNOW COVID-19 Antigen Self Test
Company
Alere Scarborough, Inc.
Model
195-170
Device description
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Published
2023-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKPCoronavirus Antigen Detection Test System.
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811877011118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811877011118008118770111188118770111180811877011118

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30
00811877012108BinaxNOW COVID-19/Flu A&B Controls20002055 2025-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.QKP2025-12-29
00050428101735CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2025-08-08
50810172700074Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
60810172700071Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
00816862027402WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
10816862027409WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
00194346415908equateWAL-MART STORES, INC.QYT2025-05-22
10194346415905equateWAL-MART STORES, INC.QYT2025-05-22
00816862027280WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
10816862027287WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
06930251802365equateWAL-MART STORES, INC.QYT2025-04-05
16930251802362equateWAL-MART STORES, INC.QYT2025-04-05
00860013635107Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635114Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00197644204359Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644380435Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644563371Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00810143620184Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.QKP2025-01-13
00816862024609WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
00816862026252WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20