FDA Device Establishments · JSON-LD · Markdown
FEI 1000231747 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 1000231747 |
|---|---|
| Owner / Operator | Takara Bio USA, Inc. (#10049222) |
| Address | 2560 Orchard Parkway, San Jose, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | PPM |
| Regulation § (21 CFR) | 864.4010 |
| Proprietary names | MMLV Reverse Transcriptase, 2000 Units; 5X One Step PrimeScript III RT-qPCR Kit, no ROX, 1000 rxns; 5X One Step PrimeScript III RT-qPCR Kit, no ROX, 200 rxns; Lyo-Ready PrimePath Probe qPCR Mix, 100 rxns; MMLV Reverse Transcriptase, 20000 Units; 5X One Step PrimeScript III RT-qPCR Kit, ROX plus, 1000 rxns; MMLV Reverse Transcriptase, 8000 Units; 5X PrimePath Probe qPCR Kit, ROX plus, 1000 rxns; 5X PrimePath Probe qPCR Kit, no ROX, 200 rxns; 5X PrimePath Probe qPCR Kit, no ROX, 1000 rxns |
Source: openFDA. Public-domain (CC0).