FDA Device Establishments · JSON-LD · Markdown
FEI 3035381641 · Manufacture Medical Device · Status: Active
| FEI Number | 3035381641 |
|---|---|
| Owner / Operator | Nuclein, LLC (#10092415) |
| Address | 500 Center Ridge Dr Ste 400, Austin, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NSU, QOF |
| Regulation § (21 CFR) | 862.2570, 866.3981 |
| Proprietary names | DASH® SARS-CoV-2 & Flu A B Positive Control; DASH® SARS-CoV-2 & Flu A/B Test; DASH® Rapid PCR Instrument; DASH® Negative Control |
Source: openFDA. Public-domain (CC0).