FDA Device Establishments · JSON-LD · Markdown
FEI 3010030414 · Manufacture Medical Device · Status: Active
| FEI Number | 3010030414 |
|---|---|
| Owner / Operator | BiOptic Inc. (#10086887) |
| Address | 4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist., New Taipei, 23141, TW |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJH |
| Regulation § (21 CFR) | 862.2310 |
| Proprietary names | iCATCHER Dx DNA Kit(250/1000/4000), iCATCHER Dx Tissue DNA Kit(250/4000), iCATCHER Dx FFPE Tissue DNA Kit, iCATCHER Dx Stool DNA Kit(250/1000/4000); iCATCHER Dx Circulating cfRNA Kit(1000/2000/4000); iCATCHER Dx Blood RNA 1000 Kit, iCATCHER Dx Tissue RNA 1000 Kit, iCATCHER Dx FFPE Tissue RNA Kit; CatchGene Dx Circulating cfDNA/cfRNA Kit(1000/4000); iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000); CatchGene Dx DNA/RNA Kit (Viral/Ultra Viral/Exosome/FFPE Tissus); iCATCHER Dx VB DNA/RNA Kit (250/1000), iCATCHER Dx FFPE Tissue DNA/RNA Kit; iCATCHER Dx Circulating cfDNA Kit(1000/2000/4000); CatchGene Dx Circulating cfRNA 1000 Kit; CatchGene Dx miRNA Kit (Cell/Exosome/Tissue/FFPE Tissue); CatchGene Dx Catch-miRNA Serum/Plasma Kit; iCATCHER 12 Dx Automated Nucleic Acid Purification System |
Source: openFDA. Public-domain (CC0).