Inbios I N T Inc

FDA Filings

This page includes the latest FDA filings for Inbios I N T Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3032562
• FEI Number: 3002606748
• Name: INBIOS INTERNATIONAL, INC.
• Owner & Operator: INBIOS INT'L INC.
• Contact Address: 307 Westlake Ave North, Suite 300 --; Seattle WA 98109 US
• Official Correspondent:
  • ESTELA I RAYCHAUDHURI
  • x-206-3445821-5405
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 307 Westlake Ave North, Suite 300 ; Queen Anne, WA 98109 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID B379STNG11 INBIOS INTERNATIONAL, INC	Strongy DetectTM IgG ELISA	2024-09-23
GUDID B379COVAF501 INBIOS INTERNATIONAL, INC	SCoV-2 Ag Detect™ Rapid Test	2024-09-23
GUDID B379COVAF201 INBIOS INTERNATIONAL, INC	SCoV-2 Ag Detect™ Rapid Test	2024-09-23
GUDID B379AAP11 INBIOS INTERNATIONAL, INC	Active Anthrax Detect Plus Rapid Test	2023-03-13
GUDID B379COV2E0 INBIOS INTERNATIONAL, INC	Smart DetectTM SARS-CoV-2 rRT-PCR Kit	2020-07-23
GUDID B379ZKM21 INBIOS INTERNATIONAL, INC	ZIKV Detect™ 2.0 IgM Capture ELISA	2019-06-03
PMN DEN180069 | QFO INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	ZIKV Detect 2.0 IgM Capture ELISA	2019-05-28
De Novo DEN180069 InBios International, Inc.	ZIKV Detect 2.0 IgM Capture ELISA	2019-05-23
GUDID B379INS0251 INBIOS INTERNATIONAL, INC	Kalazar Detect Rapid Test for Visceral Leishmanias INS025	2018-10-25
GUDID B379DNS111 INBIOS INTERNATIONAL, INC	DENV Detect NS1 ELISA DNS1-1	2018-10-25
GUDID B379CP0501 INBIOS INTERNATIONAL, INC	Chagas Detect™ Plus Rapid Test CP050	2018-10-25
GUDID B379CL0251 INBIOS INTERNATIONAL, INC	CL Detect Rapid Test for Cutaneous Leishmaniasis CL025	2018-10-25
PMN K181473 | QCU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	DENV Detect NS1 ELISA	2018-09-04
PMN K181473 InBios International, Inc.	DENV Detect NS1 ELISA	2018-08-27
GUDID B379WNMS11 INBIOS INTERNATIONAL, INC	West Nile Detect IgM Capture ELISA WNMS-1	2018-03-29
GUDID B379DDMS11 INBIOS INTERNATIONAL, INC	DENV Detect IgM Capture ELISA DDMS-1	2018-03-29
PMN K161947 | MIU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	Chagas Detect Plus Rapid Test	2017-01-10
PMN K161947 INBIOS INTERNATIONAL, INC.	Chagas Detect Plus Rapid Test	2016-12-16
PMN K141341 | PIT INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	CL Detect Rapid Test	2015-01-05
PMN K141341 INBIOS INTERNATIONAL INC.	CL DETECT RAPID TEST	2014-11-14
OSU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	Dengue Rapid Test for NS1	2012-04-21
OSU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	DENV Detect NS1 ELISA	2012-04-21
NOP INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	West Nile Dectect Capture ELISA for IgG	2012-04-21
MIU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	Chagas Detect Rapid Test for T. Cruzi	2012-04-21
LSQ INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	Scrub Typhus Detect for IgM/IgG	2012-04-21
PMN DEN100020 | OSU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	DENV Detect IgM Capture ELISA	2011-06-08
De Novo DEN100020 INBIOS INTL., INC.	DENV DETECT IGM CAPTURE ELISA	2011-04-08
PMN K041817 | NOP INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	West Nile Detect IgM Capture ELISA	2007-11-28
PMN K023483 | LOO INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	Kalazar Detect Rapid Test	2007-11-28
MVU INBIOS INTERNATIONAL, INC. [INBIOS INT'L INC.]	MULTIPLE ASR	2006-11-09
PMN K041817 INBIOS INTL., INC.	WEST NILE DETECT IGM ELISA	2004-11-19
PMN K023483 INBIOS INTL., INC.	KALAZAR DETECT	2003-05-06
PMN K001092 INBIOS INTL., INC.	GENERIC BLOOD GLUCOSE TEST STRIP	2000-07-26
PMN K992695 INBIOS INTL., INC.	INSURE PRO TEST	1999-10-18
PMN K991515 INBIOS INTL., INC.	INSURE PREGNANCY TEST	1999-05-28

Related Finance Registrations

NCAGE Code	3KJL6	INBIOS INTERNATIONAL INC
CAGE Code	3KJL6	INBIOS INTERNATIONAL INC
S.A.M. Registration	3KJL6 [4006628]	INBIOS INTERNATIONAL INC
DUNS	004006628	Inbios International Inc