Data / Medical devices / United States / Nuclein, LLC
Nuclein, LLC: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Nuclein, LLC is registered with the FDA (registration 3035381641) in Austin, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035381641
- Address
- 500 Center Ridge Dr Ste 400, Austin, TX, United States, 78753
- Owner or operator
- Nuclein, LLC (10092415)
- Roles
- Manufacturer
- First device listed
- January 3, 2025
- Registered through
- 2026
- Brand names listed
- DASH® Negative Control, DASH® Rapid PCR Instrument, DASH® SARS-CoV-2 & Flu A B Positive Control, DASH® SARS-CoV-2 & Flu A/B Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2024 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | QOF | Substantially Equivalent | Nuclein, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Instrumentation For Clinical Multiplex Test Systems
- All makers of Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Updated December 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.