Trinity Biotech P L C

FDA Filings

This page includes the latest FDA filings for Trinity Biotech P L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1318354
FEI Number1318354
NameClark Laboratories
Owner & OperatorTRINITY BIOTECH, PLC
Contact AddressIDA BUSINESS PARK BRAY --
CO. WICKLOW IE-NOTA -- IE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2823 Girts Rd
JAMESTOWN, NY 14701 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

Registration Number9681576
FEI Number3002546385
NamePAMELA NETZEL
Owner & OperatorTRINITY BIOTECH, PLC
Contact AddressIDA BUSINESS PARK BRAY --
CO. WICKLOW IE-NOTA -- IE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address60 Pineview Drive
Amherst, NY 14228 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number2245544
FEI Number1000124273
NameMARDX DIAGNOSTICS, INC.
Owner & OperatorTRINITY BIOTECH, PLC
Contact AddressIDA BUSINESS PARK BRAY --
CO. WICKLOW IE-NOTA -- IE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5919 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

Registration Number1931251
FEI Number1931251
NamePRIMUS CORPORATION
Owner & OperatorTRINITY BIOTECH, PLC
Contact AddressIDA BUSINESS PARK BRAY --
CO. WICKLOW IE-NOTA -- IE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4231 E 75th Terrace
KANSAS CITY, MO 64132 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device
Company
DeviceDate
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
Premier Hb9210 Resolution System2016-10-27
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Captia Malaria ELISA Test Kit2014-09-18
Clark Laboratories [TRINITY BIOTECH, PLC]
BioRad Malaria ELISA Test Kit2014-09-18
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Measles IgM ELISA Test Kit2014-09-17
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels Calprotectin2014-09-17
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Cytomegalovirus Total Antibody ELISA Test Kit2014-09-17
Clark Laboratories [TRINITY BIOTECH, PLC]
BioRad Cytomegalovirus Total Antibody ELISA Test Kit2014-09-17
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA TPHA Screen2014-05-30
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA TPHA Screen Diluent2014-05-30
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA TPHA Screen Controls2014-05-30
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA W.A.R.M. (Warm Autoantibody Removal Medium)2013-12-09
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA Freeze Dried Papain2013-12-06
PAMELA NETZEL [TRINITY BIOTECH, PLC]
IMMUCOR GAMMA Human Platelet Concebtrate2013-12-06
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Cryptosporidium Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Cryptosporidium Control Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Giardia Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Giardia Control Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold C. difficile Toxin A/B Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold C. difficile Toxin A/B Control Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Captia Syphilis IgM ELISA Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
BioRad Syphilis Total Antibody ELISA Test Kit2013-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
BioRad Syphilis IgM ELISA Test Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Captia Syphilis IgM ELISA Test Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
BioRad Syphilis Total Antibody ELISA Test Kit2013-11-15
Clark Laboratories [TRINITY BIOTECH, PLC]
BioRad Syphilis IgM ELISA Test Kit2013-11-15
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
Premier Hb92102012-02-09
Clark Laboratories [TRINITY BIOTECH, PLC]
Trep-Sure2011-03-25
Clark Laboratories [TRINITY BIOTECH, PLC]
Trep-Chek2011-03-25
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
TRI stat2010-11-11
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
TRI stat2010-11-11
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx2008-03-19
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx2008-03-19
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx2008-03-19
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx2008-03-19
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Anti-Cardiac Antibody IFA Test System2008-01-07
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx T. cruzi IFA Slides2008-01-07
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Borrelia burgdorferi (Lyme) IgA Marblot Strip Test System2008-01-07
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx2008-01-07
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia ENA Profile2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Macra Lp(a) Automated Kit2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech EZ HDL Cholesterol Kit2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech EZ HDL Cholesterol Kit2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Wampole ANA Screen2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
ImmuLisa ANA Screen ELISA2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia ANA Screen2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Lipase-PS2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech ACE Calibrator2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech ACE Controls2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Glucose-6-Phosphate Dehydrogenase2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech EZ HDL-C/LDL-C Calibrator2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus 2 (HSV 2) IgM2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus 1 (HSV 1) IgM2008-01-04
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold H. pylori Antigen Test Kit2008-01-04
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold H. pylori Antigen Control Kit2008-01-04
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Captia Helicobacter pylori IgA2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold H. pylori Antigen Test Kit2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold H. pylori Antigen Control Kit2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Helicobacter pylori IgA2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Mycoplasma IgM2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Mumps IgM2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus (HSV) Combined IgM2008-01-04
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2008-01-02
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Epstein Barr Virus (EBV) VCA IgM2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Marstripe2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
marblot2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
marblot2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Lyme (Borrelia burgdorferi) IFA IgM Specific Kit2008-01-02
Clark Laboratories [TRINITY BIOTECH, PLC]
MarDx Borrelia burgdorferi Lyme EIA IgM Specific Kit2008-01-02
Clark Laboratories [TRINITY BIOTECH, PLC]
MarDx Borrelia burgdorferi Lyme EIA IgG Specific Kit2008-01-02
Clark Laboratories [TRINITY BIOTECH, PLC]
MarDx Borrelia burgdorferi Lyme EIA IgG+IgM Screen Kit2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Lyme (Borrelia burgdorferi) IFA IgG Specific Kit2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Bartels Cytotoxicity Assay2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Legionella pneumophila Group 1 - 62008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Anti-Skeletal Antibody IFA Test System2008-01-02
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MarDx Glomercular Basement Membrane (GBM) IFA Test System2008-01-02
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
GLYCATED CALIBRATOR2007-12-31
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
CONTROLS FOR ABNORMAL HEMOGLOBINS2007-12-31
PRIMUS CORPORATION [TRINITY BIOTECH, PLC]
LC AFFINITY ASSAY2007-12-31
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-31
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Uni-Gold2007-12-31
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-28
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Trinity Biotech2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels Viral Trans2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Bartels2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia2007-12-26
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus 2 (HSV 2) Type Specific IgG2006-01-11
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus 1 (HSV 1) Type Specific IgG2006-01-11
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
IFA SLIDES2005-06-06
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
CONJUGATES2005-06-06
PAMELA NETZEL [TRINITY BIOTECH, PLC]
Trinity Biotech2004-05-18
TRINITY BIOTECH, PLC
CAPTIAM SYPHILIS-G ASSAY2002-01-24
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold C. difficile GDH Test Kit2001-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold C. difficile GDH Control Kit2001-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
MARBLOT STRIP TEST SYSTEM2001-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
FHA EIA TEST SYSTEM OR B.PERTUSSIS2001-11-15
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
B.PERTUSSIS PT2001-11-15
TRINITY BIOTECH, PLC
CAPTIA SYPHILIS-G ELISA TEST SYSTEM2000-11-29
TRINITY BIOTECH, PLC
UNI-GOLD H. PYLORI1999-12-21
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
Trinity Biotech Uni-Gold S. pneumoniae1999-08-03
TRINITY BIOTECH, PLC
UNI-GOLD STREP A TEST KIT1999-02-11
Clark Laboratories [TRINITY BIOTECH, PLC]
Wampole Varicella Zoster Virus IgM1997-10-01
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Varicella Zoster Virus IgM1997-10-01
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Varicella Zoster Virus IgG1997-10-01
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Chlamydia IgG1997-10-01
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Mycoplasma IgG1997-10-01
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Helicobacter pylori IgG1996-09-12
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
LEGIONELLA DFA1992-11-10
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
IFA1992-11-10
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
ANTI-PARIETAL IFA OR BARTELS LEGIO1992-11-10
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
, IFA1992-11-10
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
IFA MOUNTING MEDIA1992-11-10
MARDX DIAGNOSTICS, INC. [TRINITY BIOTECH, PLC]
COVERSLIPS1992-11-10
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Rubella IgM1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Cytomegalovirus IgM1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Toxoplasma gondii IgM1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Mumps IgG1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Cytomegalovirus IgM Capture1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Measles IgM1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Rubella IgG1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Toxoplasma gondii IgG1992-07-16
Clark Laboratories [TRINITY BIOTECH, PLC]
Captia Herpes Simplex Virus (HSV) Group IgG1992-07-16

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeSG759TRINITY BIOTECH PLC
CAGE CodeSG759TRINITY BIOTECH PLC
SEC0000888721TRINITY BIOTECH PLC of IRELAND
SEC0000890836TRINITY BIOTECH PLC /ADR/
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.