Data / Medical devices / United States / Inbios International, Inc.
Inbios International, Inc.: FDA-registered device maker in Seattle, WA, United States, 10 510(k) clearances
Inbios International, Inc. is registered with the FDA (registration 3032562) in Seattle, WA, United States. It lists 16 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032562
- FEI number
- 3002606748
- Address
- 307 Westlake Ave North, Suite 300, Seattle, WA, United States, 98109
- Owner or operator
- INBIOS INTERNATIONAL, INC. (9032122)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- November 9, 2006
- Registered through
- 2026
- Brand names listed
- 1:100 Diluted 6B6C-1/HRP Conjugate, Active Anthrax Detect Plus Rapid Test, C710 solution, CL Detect Rapid Test, COVID-19 Detect Rapid Self -Test, Chagas Detect Plus Rapid Test, Chagas Detect Rapid Test for T. Cruzi, Chikungunya Antigen for IgG and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2025 | K251595 | COVID-19 Detect Rapid Self -Test | QYT | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| August 23, 2024 | K233358 | SCoV-2 Ag Detect Rapid Test | QVF | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| February 3, 2023 | DEN220044 | Active Anthrax DetectTM Plus Rapid Test | QUU | Unknown | InBios International, Inc. | accessdata.fda.gov |
| May 23, 2019 | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | QFO | Unknown | InBios International, Inc. | accessdata.fda.gov |
| August 27, 2018 | K181473 | DENV Detect NS1 ELISA | QCU | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| December 16, 2016 | K161947 | Chagas Detect Plus Rapid Test | MIU | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| November 14, 2014 | K141341 | CL DETECT RAPID TEST | PIT | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| April 8, 2011 | DEN100020 | DENV DETECT IGM CAPTURE ELISA | OSU | Unknown | Inbios Intl., Inc. | accessdata.fda.gov |
| November 19, 2004 | K041817 | WEST NILE DETECT IGM ELISA | NOP | Substantially Equivalent | Inbios Intl., Inc. | accessdata.fda.gov |
| May 6, 2003 | K023483 | KALAZAR DETECT | LOO | Substantially Equivalent | Inbios Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dengue Serological Reagents
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- All makers of Reagent, Coronavirus Serological
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- All makers of Reagents, Specific, Analyte
Updated October 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.