Rapid Response
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…
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.
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 |
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | GTY |
| Device type | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K010582 |
| Record published | 2025-05-29 |
| Record revised | 2023-04-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| STR-15SGPU-25 | 25 | In distribution | |
| STR-15S25 | 25 | In distribution | |
| STA-15S25 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Sofia | Quidel Corp. | 4 |
| QuickVue | Quidel Corp. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| Strepaim | Germaine Laboratories, Inc. | 3 |
| Status Strep A Flip | Princeton BioMeditech Corp. | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Icon | Beckman Coulter, Inc. | 2 |
| Poly stat | Polymedco, Inc. | 2 |
| Group B Streptococcus Detection Kit(Immunochromatography) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
| Status Strep A Plus | Princeton BioMeditech Corp. | 2 |
| BioStrep® A | Princeton BioMeditech Corp. | 2 |
Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2025-07-30 | Class II | Process control | Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices. | 5 kits |
| Cypress Medical Products, Ltd. | 510(k) number | 2024-08-20 | Class II | Process control | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices. | 5 kits |
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.