Mardx Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Mardx Diagnostics 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: 2245544
• FEI Number: 1000124273
• Name: MARDX DIAGNOSTICS, INC.
• Owner & Operator: TRINITY BIOTECH, PLC
• Contact Address: IDA BUSINESS PARK BRAY --; CO. WICKLOW IE-NOTA -- IE
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5919 FARNSWORTH CT. ; CARLSBAD, CA 92008 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 05391516748858 MARDX DIAGNOSTICS, INC.	Trinity Biotech B1029-70C	2018-07-06
GUDID 05391516748841 MARDX DIAGNOSTICS, INC.	Trinity Biotech B1029-70B	2018-07-06
GUDID 05391516747998 MARDX DIAGNOSTICS, INC.	Trinity Biotech B1029-70D	2018-07-06
GUDID 05391516747974 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065M/B-A	2018-07-06
GUDID 05391516747967 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065G/B-A	2018-07-06
GUDID 05391516747950 MARDX DIAGNOSTICS, INC.	Trinity Biotech B1029-70	2018-07-06
GUDID 05391516747707 MARDX DIAGNOSTICS, INC.	Trinity Biotech 44-5017	2018-07-06
GUDID 05391516747691 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2525M	2018-07-06
GUDID 05391516747684 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2029L	2018-07-06
GUDID 05391516747677 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2022L	2018-07-06
GUDID 05391516747660 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2525G	2018-07-06
GUDID 05391516747653 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2019C	2018-07-06
GUDID 05391516747639 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2027L	2018-07-06
GUDID 05391516747622 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2023L	2018-07-06
GUDID 05391516747615 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2021L	2018-07-06
GUDID 05391516747608 MARDX DIAGNOSTICS, INC.	Trinity Biotech 32-5010	2018-07-06
GUDID 05391516747592 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7101	2018-07-06
GUDID 05391516747578 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7501	2018-07-06
GUDID 05391516747561 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7500	2018-07-06
GUDID 05391516747554 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-1524	2018-07-06
GUDID 05391516746380 MARDX DIAGNOSTICS, INC.	Trinity Biotech 32-5003	2018-07-06
GUDID 05391516746373 MARDX DIAGNOSTICS, INC.	Trinity Biotech 32-5002	2018-07-06
GUDID 05391516746366 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7102	2018-07-06
GUDID 05391516746359 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206621	2018-07-06
GUDID 05391516746342 MARDX DIAGNOSTICS, INC.	TrinityBiotech 1206620	2018-07-06
GUDID 05391516746335 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206611	2018-07-06
GUDID 05391516746328 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206610	2018-07-06
GUDID 05391516746304 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-8696P/J	2018-07-06
GUDID 05391516746298 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-8696P	2018-07-06
GUDID 05391516746281 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-8696M/J	2018-07-06
GUDID 05391516746274 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-8696M	2018-07-06
GUDID 05391516746267 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-8696G	2018-07-06
GUDID 05391516746250 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065M/B	2018-07-06
GUDID 05391516746243 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065M	2018-07-06
GUDID 05391516746236 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065G/B	2018-07-06
GUDID 05391516746229 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5065G	2018-07-06
GUDID 05391516746212 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2075M	2018-07-06
GUDID 05391516746205 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2075G	2018-07-06
GUDID 05391516746199 MARDX DIAGNOSTICS, INC.	Trinity Biotech 32-5100M	2018-07-06
GUDID 05391516746182 MARDX DIAGNOSTICS, INC.	Trinity Biotech 32-5100G	2018-07-06
GUDID 05391516746175 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7360	2018-07-06
GUDID 05391516746168 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7180	2018-07-06
GUDID 05391516746151 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7120	2018-07-06
GUDID 05391516748896 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-1502N	2018-03-29
GUDID 05391516748889 MARDX DIAGNOSTICS, INC.	Trinity Biotech 20-03012	2018-03-29
GUDID 05391516748872 MARDX DIAGNOSTICS, INC.	Trinity Biotech 20-90215	2018-03-29
GUDID 05391516748865 MARDX DIAGNOSTICS, INC.	Trinity Biotech 20-03006	2018-03-29
GUDID 05391516748834 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206651	2018-03-29
GUDID 05391516748827 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206650	2018-03-29
GUDID 05391516748810 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1204420	2018-03-29
GUDID 05391516748803 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206641	2018-03-29
GUDID 05391516748797 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206640	2018-03-29
GUDID 05391516748780 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206631	2018-03-29
GUDID 05391516748773 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206630	2018-03-29
GUDID 05391516748766 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206711	2018-03-29
GUDID 05391516748759 MARDX DIAGNOSTICS, INC.	Trinity Biotech 1206710	2018-03-29
GUDID 05391516748742 MARDX DIAGNOSTICS, INC.	Trinity Biotech 44-2020M	2018-03-29
GUDID 05391516748735 MARDX DIAGNOSTICS, INC.	Trinity Biotech 44-2020GV	2018-03-29
GUDID 05391516748728 MARDX DIAGNOSTICS, INC.	Trinity Biotech 41-1020G	2018-03-29
GUDID 05391516748711 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5020M	2018-03-29
GUDID 05391516748704 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-5020G	2018-03-29
GUDID 05391516748698 MARDX DIAGNOSTICS, INC.	Trinity Biotech 20-04648	2018-03-29
GUDID 05391516748681 MARDX DIAGNOSTICS, INC.	Trinity Biotech 20-03648	2018-03-29
GUDID 05391516748049 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5808	2018-03-29
GUDID 05391516748032 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5804	2018-03-29
GUDID 05391516748025 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5848	2018-03-29
GUDID 05391516748018 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5602	2018-03-29
GUDID 05391516748001 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5648	2018-03-29
GUDID 05391516747981 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-1523	2018-03-29
GUDID 05391516747943 MARDX DIAGNOSTICS, INC.	Trinity Biotech 90-1610	2018-03-29
GUDID 05391516747936 MARDX DIAGNOSTICS, INC.	Trinity Biotech B1029-70A	2018-03-29
GUDID 05391516747929 MARDX DIAGNOSTICS, INC.	Trinity Biotech 90-1700	2018-03-29
GUDID 05391516747912 MARDX DIAGNOSTICS, INC.	Trinity Biotech 90-1611	2018-03-29
GUDID 05391516747899 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-6196P	2018-03-29
GUDID 05391516747882 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-6111	2018-03-29
GUDID 05391516747875 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-6025	2018-03-29
GUDID 05391516747868 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-6055G	2018-03-29
GUDID 05391516747851 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-3025G	2018-03-29
GUDID 05391516747844 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-3020G	2018-03-29
GUDID 05391516747837 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7109	2018-03-29
GUDID 05391516747820 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7980	2018-03-29
GUDID 05391516747813 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5408	2018-03-29
GUDID 05391516747806 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5402	2018-03-29
GUDID 05391516747790 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5404	2018-03-29
GUDID 05391516747783 MARDX DIAGNOSTICS, INC.	Trinity Biotech 10-5448	2018-03-29
GUDID 05391516747776 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-8202	2018-03-29
GUDID 05391516747769 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-8201	2018-03-29
GUDID 05391516747752 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-1503	2018-03-29
GUDID 05391516747745 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-8203	2018-03-29
GUDID 05391516747738 MARDX DIAGNOSTICS, INC.	Trinity Biotech 41-9002	2018-03-29
GUDID 05391516747721 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-1013	2018-03-29
GUDID 05391516747714 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-1006	2018-03-29
GUDID 05391516747646 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-2017	2018-03-29
GUDID 05391516747585 MARDX DIAGNOSTICS, INC.	Trinity Biotech 90-1607	2018-03-29
GUDID 05391516746397 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-8010	2018-03-29
GUDID 05391516746311 MARDX DIAGNOSTICS, INC.	Trinity Biotech 40-6020P	2018-03-29
GUDID 05391516745673 MARDX DIAGNOSTICS, INC.	Trinity Biotech 31-8100	2018-03-29
GUDID 05391516743990 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7805	2018-03-29
GUDID 05391516743983 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7305	2018-03-29
GUDID 05391516743976 MARDX DIAGNOSTICS, INC.	Trinity Biotech 30-7205	2018-03-29
PMN K121565 | MHJ MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Cryptosporidium Test Kit	2013-11-15
PMN K121565 | MHJ MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Cryptosporidium Control Kit	2013-11-15
PMN K120001 | MHI MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Giardia Test Kit	2013-11-15
PMN K120001 | MHI MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Giardia Control Kit	2013-11-15
LLH MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold C. difficile Toxin A/B Test Kit	2013-11-15
LLH MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold C. difficile Toxin A/B Control Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Captia Syphilis IgM ELISA Test Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	BioRad Syphilis Total Antibody ELISA Test Kit	2013-11-15
LIP MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	BioRad Syphilis IgM ELISA Test Kit	2013-11-15
GMX MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx	2008-03-19
GMW MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx	2008-03-19
GMS MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx	2008-03-19
GMR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx	2008-03-19
NUK MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Anti-Cardiac Antibody IFA Test System	2008-01-07
MIV MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx T. cruzi IFA Slides	2008-01-07
LSR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Borrelia burgdorferi (Lyme) IgA Marblot Strip Test System	2008-01-07
JWL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx	2008-01-07
LYR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold H. pylori Antigen Test Kit	2008-01-04
LYR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold H. pylori Antigen Control Kit	2008-01-04
LYR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Captia Helicobacter pylori IgA	2008-01-04
PMN K964787 | LLL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Marstripe	2008-01-02
PMN K951709 | LSR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	marblot	2008-01-02
PMN K950829 | LSR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	marblot	2008-01-02
PMN K894609 | LSR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Lyme (Borrelia burgdorferi) IFA IgM Specific Kit	2008-01-02
PMN K890053 | LSR MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Lyme (Borrelia burgdorferi) IFA IgG Specific Kit	2008-01-02
PMN K833447 | MCB MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Bartels Cytotoxicity Assay	2008-01-02
PMN K832896 | LHL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Legionella pneumophila Group 1 - 6	2008-01-02
NUL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Anti-Skeletal Antibody IFA Test System	2008-01-02
MVJ MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MarDx Glomercular Basement Membrane (GBM) IFA Test System	2008-01-02
MVU MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	IFA SLIDES	2005-06-06
MVU MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	CONJUGATES	2005-06-06
MCB MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold C. difficile GDH Test Kit	2001-11-15
MCB MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold C. difficile GDH Control Kit	2001-11-15
GOX MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	MARBLOT STRIP TEST SYSTEM	2001-11-15
GOX MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	FHA EIA TEST SYSTEM OR B.PERTUSSIS	2001-11-15
GOX MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	B.PERTUSSIS PT	2001-11-15
GTZ MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold S. pneumoniae	1999-08-03
PMN K964787 MARDX DIAGNOSTICS, INC.	MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM	1997-04-08
PMN K951709 MARDX DIAGNOSTICS, INC.	MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM	1996-06-07
PMN K950829 MARDX DIAGNOSTICS, INC.	MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM	1996-06-05
PMN K960182 MARDX DIAGNOSTICS, INC.	DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM	1996-03-20
LHL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	LEGIONELLA DFA	1992-11-10
LHL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	IFA	1992-11-10
LHL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	ANTI-PARIETAL IFA OR BARTELS LEGIO	1992-11-10
LHL MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	, IFA	1992-11-10
LEB MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	IFA MOUNTING MEDIA	1992-11-10
KES MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]	COVERSLIPS	1992-11-10
PMN K894293 MARDX DIAGNOSTICS, INC.	MARDX LYME DISEASE EIA (IGM) TEST SYSTEM	1989-08-21
PMN K894224 MARDX DIAGNOSTICS, INC.	MARDX LYME DISEASE EIA (IGG) TEST SYSTEM	1989-08-21
PMN K892206 MARDX DIAGNOSTICS, INC.	MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM	1989-08-15
PMN K890053 MARDX DIAGNOSTICS, INC.	MARDX LYME DISEASE IGG IFA TEST SYSTEM	1989-04-18

Related Finance Registrations

NCAGE Code	0PAE9	MARDX DIAGNOSTICS INC
NCAGE Code	1L9C8	MARDX DIAGNOSTICS INC
CAGE Code	0PAE9	MARDX DIAGNOSTICS INC
CAGE Code	1L9C8	MARDX DIAGNOSTICS INC