Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032562

FEI Number

3002606748

Entity Name

INBIOS INTERNATIONAL, INC.

City/State/Country

Seattle, WA, US

Establishment Address

307 Westlake Ave North, Suite 300, Seattle, WA 98109, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

INBIOS INTERNATIONAL, INC. (Owner Number: 9032122)

Owner / Operator Contact Address

307 Westlake Ave North, Suite 300, Seattle, WA 98109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENV Detect NS1 ELISA DENV Detect IgM Capture ELISA SCoV-2 Ag Detect Rapid Test Kalazar Detect Rapid Test SCoV-2 Ag Detect Rapid Test SCoV-2 Ag Detect Rapid Self-Test ZIKV Detect 2 IgM Capture ELISA Strongy DetectTM IgG ELISA Active Anthrax Detect Plus Rapid Test COVID-19 Detect Rapid Self -Test CL Detect Rapid Test DENV Detect NS1 ELISA Dengue Rapid Test for NS1 DENV Detect IgG ELISA West Nile Detect IgM Capture ELISA SCoV-2 Detect IgM ELISA SCoV-2 Detect IgG ELISA West Nile Dectect Capture ELISA for IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QCU	Dengue Virus Antigen Assay	Microbiology	Class 2	866.3945	2018-09-04
OSU	Dengue Serological Reagents	Microbiology	Class 2	866.3945	2011-06-08
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2024-10-24
LOO	Reagent, Leishmanii Serological	Microbiology	Class 1	866.3870	2007-11-28
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2022-04-13
QFO	Zika Virus Serological Reagents	Microbiology	Class 2	866.3935	2019-05-28
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2024-06-13
QUU	Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples	Microbiology	Class 2	866.3046	2023-03-01
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2025-11-19
PIT	Leishmania Spp. Antigen Detection Assay	Microbiology	Class 1	866.3870	2015-01-05
OSU	Dengue Serological Reagents	Microbiology	Class 2	866.3945	2012-04-21
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2007-11-28
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2022-04-13
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2012-04-21

Official Correspondent

ESTELA RAYCHAUDHURI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INBIOS INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K251289	Guangzhou Wondfo Biotech Co., Ltd.	WELLlife COVID-19 Antigen Test Rx	2025-10-22
K191578	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control	2019-07-17
K241317	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	2024-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032562. Last updated year: 2026. Please use registration number 3032562 when referencing this establishment in official correspondence.