Ihealth
The FDA filing identifies iHealth as the iHealth COVID-19 Antigen Rapid Test, a visually read lateral-flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen.…
The FDA filing identifies iHealth as the iHealth COVID-19 Antigen Rapid Test, a visually read lateral-flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen.
It is intended for anterior nasal swab specimens from people with COVID-19 signs and symptoms within six days after onset. It is for home use by people aged 15 or older testing themselves, or adults testing children aged 2 or older.
Test Procedure and Reading
A self-collected anterior-nares swab is placed in reagent, and liquid is added to the test card. The filing describes a test line and control line when antigen is present, and a control line alone when it is absent or at very low levels.
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
Record
| Listed by | iHealth Labs, 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 | Manufacturer |
| 510(k) | K233842 |
| Record published | 2026-07-21 |
| Record revised | 2026-07-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12, pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ICO-3000 | 10 | In distribution | |
| ICO-3000 | 5 | In distribution | |
| ICO-3000 | 6 | In distribution | |
| ICO-3000 | 2 | In distribution | |
| ICO-3000 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WELLlife™ | Wondfo USA Co., Ltd. | 12 |
| CorDx Tyfast | Coretests, Inc. | 8 |
| SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box | Watmind USA | 4 |
| BinaxNOW COVID-19 Antigen Self Test | Alere Scarborough, Inc. | 4 |
| Case SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | Watmind USA | 4 |
| CareSuperb COVID-19 Antigen Home Test | Access Bio, Inc. | 3 |
| equate | Wal Mart Stores, Inc | 2 |
| Retail Display Box – SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tes | Watmind USA | 2 |
| CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | Watmind USA | 2 |
| CVS Health At Home COVID-19 Test Kit | Diagnostic Hybrids, Inc. | 2 |
| GenaCheck® COVID-19 Rapid Self-Test 20T | Genabio Diagnostics Inc | 1 |
| Flowflex COVID-19 Antigen Home Test | Acon Laboratories, Inc. | 1 |
Showing 12 of 16. All products under Over-The-Counter Covid-19 Antigen Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233842 | 2024-05-31 |
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.