FDA Device Establishments · JSON-LD · Markdown
FEI 3028107593 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3028107593 |
|---|---|
| Owner / Operator | Hian (Hong Kong) Co., Limited (#10088625) |
| Address | Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong., Hong Kong, 94085, HK |
| Mandatory US Agent | IHEALTH LABS, INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | SCA |
| Regulation § (21 CFR) | 866.3987 |
| Proprietary names | iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000) |
Source: openFDA. Public-domain (CC0).