Medical Device Manufacturer · US , Seattle , WA

InBios International, Inc. - FDA 510(k) Cleared Devices

7 submissions · 5 cleared · Since 2014

Recent clearances: COVID-19 Detect Rapid Self -Test, SCoV-2 Ag Detect Rapid Test, DENV Detect NS1 ELISA

7

Total

5

Cleared

2

Denied

FDA 510(k) Regulatory Record - InBios International, Inc. Microbiology ✕

7 devices

1-7 of 7

Cleared Oct 12, 2025

COVID-19 Detect Rapid Self -Test

Microbiology · 138d

Cleared Aug 23, 2024

SCoV-2 Ag Detect Rapid Test

Microbiology · 329d

Not Cleared Feb 03, 2023

Active Anthrax DetectTM Plus Rapid Test

DEN220044 · QUU

Microbiology · 210d

Not Cleared May 23, 2019

ZIKV Detect 2.0 IgM Capture ELISA

DEN180069 · QFO

Microbiology · 148d

Cleared Aug 27, 2018

DENV Detect NS1 ELISA

Microbiology · 84d

Cleared Dec 16, 2016

Chagas Detect Plus Rapid Test

Microbiology · 155d

Cleared Nov 14, 2014

CL DETECT RAPID TEST

Microbiology · 177d