Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nuclein LLC with 3 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated Oct 21, 2026: DASH Flu A/B Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 21, 2026 | DASH Flu A/B TestK261347 · OCC | 510(k) clearances |
| Oct 22, 2025 | Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.Class II · Due to a software issue | Device recalls |
| Jun 25, 2025 | Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 ProdClass II · Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). | Device recalls |
| Jun 25, 2025 | 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 TestClass II · Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative r | Device recalls |
| Dec 20, 2024 | DASH® SARS-CoV-2 & Flu A/B TestK241652 · QOF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
