1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab…
1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab Guards (2), Nasal Swabs (2); 5 Test per kit (L03A-R1645): Test Cassettes (5), Extraction Buffer Tubes (5), Swab Guards (5), Nasal Swabs (5); 25 Test per kit (L03A-R1745): Test Cassettes (25), Extraction Buffer Tubes (25), Swab Guards (25), Nasal Swabs (25)
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Flowflex Plus RSV + Flu A/B + Covid Home Test | Listed by | Acon Laboratories, Inc., United States |
| FDA product code | SCA |
| Device type | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3987 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2025-11-06 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| 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 12, inner pack of 12, carton of 48, kit box of 2, kit box, tray of 18 |
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.