Nuclein LLC
FDA Regulatory Profile
Nuclein LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2861-2026, Class II) was initiated on June 25, 2025. Its most recent 510(k) clearance was granted on December 20, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2861-2026 | Class II | Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number | June 25, 2025 |
| Z-2274-2025 | Class II | DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu tes | June 25, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test | December 20, 2024 |