Home GUDID 00722066010754 Rapid Response
Primary DI 00722066010754
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
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name GTY Antigens, All Groups, Streptococcus Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTY Antigens, All Groups, Streptococcus Spp. Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10722066010751 Primary GS1 0 00722066010754 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10722066010751 10722066010751 00722066010754 00722066010754 722066010754 0722066010754
GMDN Terms# Term, Definition table Term Definition Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical A 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 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20612479281558 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 20612479281565 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 10612479281575 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 10612479281582 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 00810107290132 Flowflex Plus Strep A Rapid Test Cassette Acon Laboratories, Inc. GTY 2025-12-01 00810107290156 Flowflex Plus Strep A Rapid Test Strip Acon Laboratories, Inc. GTY 2025-12-01 20810107290143 Flowflex Plus Strep A Rapid Test Cassette Acon Laboratories, Inc. GTY 2025-12-01 00810107290187 Flowflex Plus Strep A Rapid Test Strip Acon Laboratories, Inc. GTY 2025-12-01 10722066010751 Rapid Response BTNX Inc GTY 2025-05-29 30888277191888 MEDLINE MEDLINE INDUSTRIES, INC. GTY 2023-12-18 10722066006846 Rapid Response BTNX Inc GTY 2023-08-14 00722066006849 Rapid Response BTNX Inc GTY 2023-08-14 00816862023725 Preview WONDFO USA CO., LTD. GTY 2023-08-03 10816862023722 Preview WONDFO USA CO., LTD. GTY 2023-08-03 00695684755256 StrepAim GERMAINE LABORATORIES, INC GTY 2023-01-17 06974849369120 Group B Streptococcus Detection Kit(Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369137 Group B Streptococcus Detection Kit(Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369144 Group A Streptococcus Antigen Detection Kit (Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369151 Group A Streptococcus Antigen Detection Kit (Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 20885380183628 CARDINAL HEALTH Cardinal Health 200, LLC GTY 2022-08-29 10885380183621 CARDINAL HEALTH Cardinal Health 200, LLC GTY 2022-08-29 00816862023589 Preview WONDFO USA CO., LTD. GTY 2021-08-20 10816862023586 Preview WONDFO USA CO., LTD. GTY 2021-08-20 05713106821756 S. pneumoniae reference strain 1 Ssi Diagnostica A/S GTY 2021-08-01 05713106821763 S. pneumoniae reference strain 2 Ssi Diagnostica A/S GTY 2021-08-01 05713106821770 S. pneumoniae reference strain 3 Ssi Diagnostica A/S GTY 2021-08-01 05713106821787 S. pneumoniae reference strain 4 Ssi Diagnostica A/S GTY 2021-08-01 05713106821794 S. pneumoniae reference strain 5 Ssi Diagnostica A/S GTY 2021-08-01 05713106821800 S. pneumoniae reference strain 6A Ssi Diagnostica A/S GTY 2021-08-01 05713106821817 S. pneumoniae reference strain 6B Ssi Diagnostica A/S GTY 2021-08-01