Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 10722066010751
• Version / Model: STR-15SGPU-25
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-05-29
• Public Version: 1
• Public Version Date: 2025-06-06
• Public Version Status: New
• Public Device Record Key: 4a29f7c6-c0d9-4b29-9485-d51b623edc1e

Device Description

Rapid Response Strep A Detection Strip (Throat Swab)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51707	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00722066010754	GS1
Primary	10722066010751	GS1