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Sign in to claim this brandNuclein, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 500 Center Ridge Dr Ste 400, Austin, TX, 78753
- Website
- nuclein.com
- —
- —
- [email protected]
- Phone
- 1-888-992-3274
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3035381641
- DUNS Number
- 093432054
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit | SG-0008 | FDA UDI | Class II | Active |
| DASH® Negative Control Swabs Kit | SG-0010 | FDA UDI | Class II | Active |
| DASH® SARS-CoV-2 & Flu A/B Test Kit | SG-0006 | FDA UDI | Class II | Active |
| DASH® Rapid PCR Instrument | DASH-0002 | FDA UDI | Class II | Active |
| DASH® SARS-CoV-2 & Flu A/B Test | K241652 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 25, 2025 | Z-2274-2025 | — | open, classified | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |