InBios International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 6
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251595 | COVID-19 Detect Rapid Self -Test | October 12, 2025 |
| K233358 | SCoV-2 Ag Detect Rapid Test | August 23, 2024 |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | February 3, 2023 |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | May 23, 2019 |
| K181473 | DENV Detect NS1 ELISA | August 27, 2018 |
| K161947 | Chagas Detect Plus Rapid Test | December 16, 2016 |
| K141341 | CL DETECT RAPID TEST | November 14, 2014 |