FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066008031
Brand
Rapid Response
Company
BTNX Inc
Model
RSV-19C20
Device description
Rapid Response RSV Test Cassette - A rapid test for the qualitative detection of Respiratory Syncytial Virus fusion protein from nasopharyngeal swab or nasal aspirate specimens. For in vitro diagnostic use.
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K021789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021789000QUICKLAB RSVIntegrated Biotechnology Corp.2002-11-20GQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066008031PrimaryGS10
00722066008034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600803110722066008031
00722066008034007220660080347220660080340722066008034

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from respiratory syncytial virus (RSV) 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
251005005
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29

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
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
10811877011207BinaxNOW RSV Control Swab KitAlere 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