Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035381641

FEI Number

3035381641

Entity Name

Nuclein, LLC

City/State/Country

Austin, TX, US

Establishment Address

500 Center Ridge Dr Ste 400, Austin, TX 78753, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nuclein, LLC (Owner Number: 10092415)

Owner / Operator Contact Address

8305 Cross Park Drive, Austin, TX 78754, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241652

PMA Number

N/A

All Registered Proprietary Names

DASH® Negative Control DASH® Rapid PCR Instrument DASH® SARS-CoV-2 & Flu A B Positive Control DASH® SARS-CoV-2 & Flu A/B Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-01-03
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2025-01-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuclein, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014515702	Nuclein, LLC	Austin, TX, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035381641. Last updated year: 2026. Please use registration number 3035381641 when referencing this establishment in official correspondence.