Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Strep A Test (Throat Swab) - for the qualitative detection of Streptococcus pyogenes (Strep A) antigens from throat swab specimens. For professional, prescription in vitro diagnostic use. FDA UDI
- Model / Reference
- STA-15S25 FDA UDI
- Description
- Rapid Response Strep A Test (Throat Swab) - for the qualitative detection of Streptococcus pyogenes (Strep A) antigens from throat swab specimens. For professional, prescription in vitro diagnostic use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066006846 FDA UDI
- 510(k) Number
- K212623 FDA UDI
- FDA Product Code
- GTY FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.
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- Status Strep A Flip — PRINCETON BIOMEDITECH CORP. · Class I
- Status Strep A Flip — PRINCETON BIOMEDITECH CORP. · Class I
- Status Strep A Plus — PRINCETON BIOMEDITECH CORP. · Class I
- Accutest Value+ Strep A Rapid Test Strip — JANT PHARMACAL CORP. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 457d26a9-048b-4f5e-a494-1c70cef4ebe1 34 fields · synced May 30, 2026