# InBios International, Inc.

- Location (FDA's records): Seattle, WA
- FDA decisions: 7 (2014–2025): 5 510(k) clearances and 2 De Novo grants
- Product codes: QFO (1), MIU (1), PIT (1), QVF (1), QUU (1), QCU (1), QYT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- First Light Diagnostics, Inc.: 1 (https://510kreport.com/company/first-light-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Chembio Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/chembio-diagnostic-systems)
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Its most-cited devices
- DEN180069: ZIKV Detect 2.0 IgM Capture ELISA (2019), cited by 3
- DEN220044: Active Anthrax DetectTM Plus Rapid Test (2023), cited by 1

## Recent decisions
- K251595: COVID-19 Detect Rapid Self -Test (Oct 12, 2025)
- K233358: SCoV-2 Ag Detect Rapid Test (Aug 23, 2024)
- DEN220044: Active Anthrax DetectTM Plus Rapid Test (Feb 3, 2023)
- DEN180069: ZIKV Detect 2.0 IgM Capture ELISA (May 23, 2019)
- K181473: DENV Detect NS1 ELISA (Aug 27, 2018)
- K161947: Chagas Detect Plus Rapid Test (Dec 16, 2016)
- K141341: CL Detect Rapid Test (Nov 14, 2014)

Source page: https://510kreport.com/company/inbios-international