DRG International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2265-2025 | Class III | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product De | June 4, 2025 |
| Z-0921-2025 | Class II | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | October 7, 2024 |
| Z-0258-2025 | Class III | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic | September 13, 2024 |
| Z-2622-2024 | Class III | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An e | July 5, 2024 |
| Z-0896-2022 | Class II | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) | December 21, 2021 |
| Z-0310-2022 | Class II | Total Thyroxine (T4) ELISA; REF EIA-1781 | October 18, 2021 |