Clark Laboratories FDA Filings

FDA Filings

Device Company	Device	Date
OAX Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Captia Malaria ELISA Test Kit	2014-09-18
OAX Clark Laboratories [TRINITY BIOTECH, PLC]	BioRad Malaria ELISA Test Kit	2014-09-18
PMN K140455 \| PCL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Measles IgM ELISA Test Kit	2014-09-17
NXO Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels Calprotectin	2014-09-17
LFZ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Cytomegalovirus Total Antibody ELISA Test Kit	2014-09-17
LFZ Clark Laboratories [TRINITY BIOTECH, PLC]	BioRad Cytomegalovirus Total Antibody ELISA Test Kit	2014-09-17
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit	2013-11-15
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit	2013-11-15
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit	2013-11-15
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Captia Syphilis IgM ELISA Test Kit	2013-11-15
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	BioRad Syphilis Total Antibody ELISA Test Kit	2013-11-15
LIP Clark Laboratories [TRINITY BIOTECH, PLC]	BioRad Syphilis IgM ELISA Test Kit	2013-11-15
PMN K001552 \| LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trep-Sure	2011-03-25
PMN K001552 \| LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Trep-Chek	2011-03-25
PMN K993839 \| LLL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia ENA Profile	2008-01-04
PMN K992665 \| DFC Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Macra Lp(a) Automated Kit	2008-01-04
PMN K972041 \| LBS Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech EZ HDL Cholesterol Kit	2008-01-04
PMN K972041 \| JIS Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech EZ HDL Cholesterol Kit	2008-01-04
PMN K954723 \| LKJ Clark Laboratories [TRINITY BIOTECH, PLC]	Wampole ANA Screen	2008-01-04
PMN K954723 \| LKJ Clark Laboratories [TRINITY BIOTECH, PLC]	ImmuLisa ANA Screen ELISA	2008-01-04
PMN K954723 \| LKJ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia ANA Screen	2008-01-04
PMN K941085 \| CHI Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Lipase-PS	2008-01-04
PMN K930477 \| JIS Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech ACE Calibrator	2008-01-04
PMN K860453 \| JJX Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech ACE Controls	2008-01-04
PMN K802568 \| KHG Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Glucose-6-Phosphate Dehydrogenase	2008-01-04
PMN K001005 \| JIS Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech EZ HDL-C/LDL-C Calibrator	2008-01-04
MYF Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus 2 (HSV 2) IgM	2008-01-04
MXJ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus 1 (HSV 1) IgM	2008-01-04
LYR Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold H. pylori Antigen Test Kit	2008-01-04
LYR Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech Uni-Gold H. pylori Antigen Control Kit	2008-01-04
LYR Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Helicobacter pylori IgA	2008-01-04
LJZ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Mycoplasma IgM	2008-01-04
LJY Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Mumps IgM	2008-01-04
LGC Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus (HSV) Combined IgM	2008-01-04
PMN K991074 \| MJH Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2008-01-02
PMN K980596 \| LSE Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Epstein Barr Virus (EBV) VCA IgM	2008-01-02
PMN K894293 \| LSR Clark Laboratories [TRINITY BIOTECH, PLC]	MarDx Borrelia burgdorferi Lyme EIA IgM Specific Kit	2008-01-02
PMN K894224 \| LSR Clark Laboratories [TRINITY BIOTECH, PLC]	MarDx Borrelia burgdorferi Lyme EIA IgG Specific Kit	2008-01-02
PMN K892206 \| LSR Clark Laboratories [TRINITY BIOTECH, PLC]	MarDx Borrelia burgdorferi Lyme EIA IgG+IgM Screen Kit	2008-01-02
PMN K980912 \| LSE Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K980598 \| LLM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K973123 \| LSE Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K971157 \| JHO Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech	2007-12-26
PMN K971157 \| DFC Clark Laboratories [TRINITY BIOTECH, PLC]	Trinity Biotech	2007-12-26
PMN K961765 \| MOB Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K961764 \| MOB Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K951549 \| LLM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K941358 \| JNL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K940253 \| LJM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K940251 \| DBM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935987 \| JSM Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K935987 \| JSM Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels Viral Trans	2007-12-26
PMN K935419 \| LLL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935418 \| LLL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935417 \| LLL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935416 \| LJM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935415 \| LJM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935414 \| LJM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K935413 \| LLL Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K924056 \| DHR Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K923537 \| LRM Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K904524 \| LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K883670 \| GNP Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K883282 \| GQO Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K883281 \| GQO Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K883102 \| GQI Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K834136 \| KIT Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K834125 \| JSM Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K834122 \| KIT Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K834116 \| KIT Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K834115 \| JSK Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K834113 \| KIT Clark Laboratories [TRINITY BIOTECH, PLC]	Bartels	2007-12-26
PMN K033083 \| LSR Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K033051 \| MJH Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K014233 \| LIP Clark Laboratories [TRINITY BIOTECH, PLC]	Captia	2007-12-26
PMN K033106 \| MYF Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus 2 (HSV 2) Type Specific IgG	2006-01-11
PMN K033105 \| MXJ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus 1 (HSV 1) Type Specific IgG	2006-01-11
PMN K914022 \| LFY Clark Laboratories [TRINITY BIOTECH, PLC]	Wampole Varicella Zoster Virus IgM	1997-10-01
PMN K914022 \| LFY Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Varicella Zoster Virus IgM	1997-10-01
PMN K883427 \| GQX Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Varicella Zoster Virus IgG	1997-10-01
PMN K033079 \| LJC Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Chlamydia IgG	1997-10-01
PMN K033064 \| LON Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Mycoplasma IgG	1997-10-01
PMN K033067 \| LYR Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Helicobacter pylori IgG	1996-09-12
PMN K921573 \| LFX Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Rubella IgM	1992-07-16
PMN K921011 \| LFZ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Cytomegalovirus IgM	1992-07-16
PMN K920702 \| LGD Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Toxoplasma gondii IgM	1992-07-16
PMN K897006 \| LJY Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Mumps IgG	1992-07-16
PMN K896295 \| LFZ Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Cytomegalovirus IgM Capture	1992-07-16
PMN K873925 \| LJB Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Measles IgM	1992-07-16
PMN K873088 \| LFX Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Rubella IgG	1992-07-16
PMN K871905 \| LGD Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Toxoplasma gondii IgG	1992-07-16
PMN K033059 \| LGC Clark Laboratories [TRINITY BIOTECH, PLC]	Captia Herpes Simplex Virus (HSV) Group IgG	1992-07-16

Registration Number	1318354
FEI Number	1318354
Name	Clark Laboratories
Owner & Operator	TRINITY BIOTECH, PLC
Contact Address	IDA BUSINESS PARK BRAY -- CO. WICKLOW IE-NOTA -- IE
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	2823 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