FDA Device Establishments · JSON-LD · Markdown
FEI 3004635103 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3004635103 |
|---|---|
| Owner / Operator | GUANGZHOU WONDFO BIOTECH CO., LTD. (#9064561) |
| Address | No.8 Lizhishan Road, Science City, Huangpu District, Guangzhou Guangdong, 510663, CN |
| Mandatory US Agent | LSI International Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 11 |
| Product codes (top 20) | QBF, NGL, NFT, LCM, PTH, NGG, NFW, NFY, NFV, QAW, PTG |
| Regulation § (21 CFR) | 862.3700, 862.3650, 862.3100, 862.3150, 862.3610, 862.3870, 862.3250, 862.3170, 862.3910, 862.3620 |
| Proprietary names | PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC20); SAFElife T-Dip Multi-Drug Urine Test Panel Dx |
Source: openFDA. Public-domain (CC0).