Thera Test Laboratories, Inc.
Thera Test Laboratories, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2382-2021, Class II) was initiated on October 5, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2382-2021 | Class II | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 | October 5, 2020 |
| Z-2381-2021 | Class II | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 | July 30, 2020 |