Sekisui Diagnostics Llc
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0015-2014 | Class II | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E ( | September 16, 2013 |
| Z-0463-2013 | Class II | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination o | October 24, 2012 |
| Z-2431-2012 | Class II | Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activat | August 28, 2012 |
| Z-1902-2012 | Class II | MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for t | May 29, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | April 18, 2025 |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | April 3, 2020 |
| K182001 | Acucy Influenza A&B Test with the Acucy System | December 17, 2018 |
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | June 22, 2018 |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | December 28, 2012 |
| K123182 | OSOM INFLUENZA A&B TEST MODEL 190 | November 5, 2012 |