FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066010751
Brand
Rapid Response
Company
BTNX Inc
Model
STR-15SGPU-25
Device description
Rapid Response Strep A Detection Strip (Throat Swab)
Published
2025-05-29
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
GTYAntigens, All Groups, Streptococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066010751PrimaryGS10
00722066010754Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206601075110722066010751
00722066010754007220660107547220660107540722066010754

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria 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
25
Kit
true
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
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29
00722066010754Rapid ResponseSTR-15SGPU-252025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479281558McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
20612479281565McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
10612479281575McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
10612479281582McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
00810107290132Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290156Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
20810107290143Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290187Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
00722066010754Rapid ResponseBTNX IncGTY2025-05-29
30888277191888MEDLINEMEDLINE INDUSTRIES, INC.GTY2023-12-18
10722066006846Rapid ResponseBTNX IncGTY2023-08-14
00722066006849Rapid ResponseBTNX IncGTY2023-08-14
00816862023725PreviewWONDFO USA CO., LTD.GTY2023-08-03
10816862023722PreviewWONDFO USA CO., LTD.GTY2023-08-03
00695684755256StrepAimGERMAINE LABORATORIES, INCGTY2023-01-17
06974849369120Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369137Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369144Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369151Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
20885380183628CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
10885380183621CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
00816862023589PreviewWONDFO USA CO., LTD.GTY2021-08-20
10816862023586PreviewWONDFO USA CO., LTD.GTY2021-08-20
05713106821756S. pneumoniae reference strain 1Ssi Diagnostica A/SGTY2021-08-01
05713106821763S. pneumoniae reference strain 2Ssi Diagnostica A/SGTY2021-08-01
05713106821770S. pneumoniae reference strain 3Ssi Diagnostica A/SGTY2021-08-01
05713106821787S. pneumoniae reference strain 4Ssi Diagnostica A/SGTY2021-08-01
05713106821794S. pneumoniae reference strain 5Ssi Diagnostica A/SGTY2021-08-01
05713106821800S. pneumoniae reference strain 6ASsi Diagnostica A/SGTY2021-08-01
05713106821817S. pneumoniae reference strain 6BSsi Diagnostica A/SGTY2021-08-01