Quest International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0534-2026 | Class II | Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Mode | October 1, 2025 |
| Z-2552-2025 | Class II | Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Mod | July 17, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181514 | SeraQuest HSV Type 2 Specific IgG | June 13, 2019 |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | October 1, 2016 |
| K152353 | SeraQuest HSV Type 2 Specific IgG | May 13, 2016 |