FDA.reportPublic FDA data

BinaxNOW RSV Control Swab Kit

Primary DI
10811877011207
Brand
BinaxNOW RSV Control Swab Kit
Company
Alere Scarborough, Inc.
Model
430-080
Device description
Control Swabs intended for use only with BinaxNOW RSV products.
Published
2020-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032166000BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065Binax, Inc.2003-10-21GQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877011207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701120710811877011207

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen.

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
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950921308096CLUNGENEHangzhou Clongene Biotech Co., Ltd.GQG2026-04-11
00742860100666OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
10742860100663OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
20612479277278McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
40612479277289McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
00810160810377Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00810160810360Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00612479269880McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00612479269897McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00895160002854Nano-Check RSV TestNANO-DITECH CORPORATIONGQG2024-08-08
05032384502950IMAGEN Respiratory Syncytial Virus (RSV)OXOID LIMITEDGQG2024-06-19
10722066008031Rapid ResponseBTNX IncGQG2024-02-21
00722066008034Rapid ResponseBTNX IncGQG2024-02-21
08033891327668CHORUS RESPIRATORY SYNCYTIAL VIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGQG2024-01-22
10694644700036Easy Lab Pro RSVAMERICAN BIO MEDICA CORPORATIONGQG2023-01-12
00840733101847TRU RSVMERIDIAN BIOSCIENCE, INC.GQG2020-12-09
00840733101977FLU/RSV Positive ControlMERIDIAN BIOSCIENCE, INC.GQG2020-11-17
10811877010484BinaxNOW Nasopharyngeal Swab Accessory KitAlere Scarborough, Inc.GQG2020-09-16
10811877011160BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011177BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011184BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011191BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
30014613201939QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202226QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202424SofiaQUIDEL CORPORATIONGQG2018-11-10
30014613202608SofiaQUIDEL CORPORATIONGQG2018-11-10
00382902560388BD Veritor™ System For Rapid Detection of RSV - CLIA waived kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
00382902560425BD Veritor™ System For Rapid Detection of RSV - Laboratory kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
10627966005183RAMP® RSV TEST KIT; 25 TESTSResponse Biomedical CorpGQG2017-08-31
10627966005206RAMP® RSV Control SwabsResponse Biomedical CorpGQG2017-08-31