1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5…
1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L031-125N5): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L031-125P5): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (1), Tianjin (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Flowflex COVID-19 Antigen Home Test | Listed by | Acon Laboratories, Inc., United States |
| FDA product code | QYT |
| Device type | Over-The-Counter Covid-19 Antigen Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3984 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2026-01-26 |
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 | Inner pack of 12, inner pack of 6, carton of 8, carton of 24, carton of 48, kit box |
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.