Nuclein LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2274-2025Class IIDASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu tesJune 25, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K241652DASH® SARS-CoV-2 & Flu A/B TestDecember 20, 2024