FDA.reportPublic FDA data

INBIOS INTERNATIONAL, INC.

Matched from indexed company URL: INBIOS INTERNATIONAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30325623002606748INBIOS INTERNATIONAL, INC.1N2026-01-01307 Westlake Ave North, Suite 300 Seattle WA US 98109

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
541291324787853K251595COVID-19 Detect Rapid Self -TestQYT2025-10-12
541291253080511K233358SCoV-2 Ag Detect Rapid TestQVF2024-08-23
541291615091714K181473DENV Detect NS1 ELISAQCU2018-08-27
541291612924707K161947Chagas Detect Plus Rapid TestMIU2016-12-16
541291999490068K141341CL DETECT RAPID TESTPIT2014-11-14
541291931093510K041817WEST NILE DETECT IGM ELISANOP2004-11-19
541291770233899K023483KALAZAR DETECTLOO2003-05-06
541291998872151DEN220044Active Anthrax DetectTM Plus Rapid TestQUU2023-02-03
541291112621240DEN180069ZIKV Detect 2.0 IgM Capture ELISAQFO2019-05-23
541291519469685DEN100020DENV DETECT IGM CAPTURE ELISAOSU2011-04-08
541291048036257
541291068851755
541291091336268
541291307216959
541291449960101
541291576274452
541291682471078
541291824054784
541291870453396

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QYT12025-10-12
QVF12024-08-23
QUU12023-02-03
QFO12019-05-23
QCU12018-08-27
MIU12016-12-16
PIT12014-11-14
OSU12011-04-08
NOP12004-11-19
LOO12003-05-06

PMN#

GUDID#