ClearanceBrief
Company · US

Nuclein LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (1 in 12 months)
3recalls (2 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
NSUInstrumentation For Clinical Multiplex Test Systems2
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents2
OCCRespiratory Virus Panel Nucleic Acid Assay System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 21, 2026K261347DASH Flu A/B Test
Nuclein, LLC
OCC
Dec 20, 2024K241652DASH® SARS-CoV-2 & Flu A/B Test
Nuclein, LLC
QOF

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 14, 2026Nuclein LLC
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 Instrum
Open, Classified		 NSUK241652
Aug 3, 2026Nuclein LLC
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)
Open, Classified		 NSUK241652
Aug 6, 2025Nuclein LLC
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 t
Open, Classified		 QOFK241652
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