Flowflex Plus Strep a Rapid Test Cassette
25 Test per kit (L03A-R0115):Test Cassettes (27), Test Tubes (27), Dropper Tips (27), Throat Swabs (27), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)
6manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
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 | Acon Laboratories, Inc., United States |
|---|---|
| FDA product code | GTY |
| Device type | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2025-12-01 |
| Record revised | 2026-01-15 (version 2) |
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 |
| Storage | Special storage condition: The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on t |
| Packaging | Carton of 24, kit box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L03A-R0115 | 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 |
| Rapid Response | Btnx 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 |
Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251697 | 2025-11-26 |
| K031784 | 2003-07-14 |
| K023766 | 2003-02-10 |
| K010582 | 2001-05-07 |
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.