Data / Medical devices / United States / Nuclein, LLC

Nuclein, LLC: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance

Name: Nuclein, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nuclein, LLC is registered with the FDA (registration 3014515702) 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. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Nuclein, LLC

FDA registration number: 3014515702
Address: 8305 Cross Park Dr, Austin, TX, United States, 78754
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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 22, 2025	99356	Class II	Ongoing	Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH Rapid PCR Instrument (DASH Instrument	Due to a software issue	accessdata.fda.gov
June 25, 2025	99360	Class II	Ongoing	Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fl	Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).	accessdata.fda.gov
June 25, 2025	97228	Class II	Ongoing	DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10	Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. 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.