FDA Device Establishments · JSON-LD · Markdown
FEI 3008517993 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3008517993 |
|---|---|
| Owner / Operator | Zhejiang Orient Gene Biotech Co., Ltd (#10033347) |
| Address | 3787 East Yangguang Avenue, Dipu Street, Anji, Huzhou Zhejiang, 313300, CN |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OSL |
| Regulation § (21 CFR) | 864.6550 |
| Proprietary names | External Controls Second Generation FOB Rapid Test Cassette |
Source: openFDA. Public-domain (CC0).