Manufacturer

Trinitybiotech

United StatesLegal entities : Trinity Biotech USA

First countries of placing on the market declared in EUDAMED : Austria, Ireland

EU representative : TrinityBiotech (Ireland)

14 categories, 34 models including 34 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Ebv vca igg	W010504040105	Captia EBV VCA (P-18) IgG Test Kit 232470098/79 Captia EBV VCA (P-18) IgG Test Kit 232470198/79 Captia EBV VCA IgG Test Kit 232570098/79 Platelia EBV-VCA IgG Test Kit 7293798/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Bio-Rad Malaria EIA Test Kit 7252698/79 Bio-Rad Malaria EIA Test Kit 7252898/79 Captia Malaria EIA Test Kit 232247198/79 Captia™ Malaria EIA98/79	– 98/79	EUDAMED record Report an error
Ebv ea igg	W010504040108	Captia EBV EA-D IgG Test Kit 232500098/79 Captia EBV EA-D IgG Test Kit 232500198/79 Platelia EBV-EA-D IgG Test Kit 7293898/79	– 98/79	EUDAMED record Report an error
Ebv ebna igg	W010504040106	Captia EBNA-1 IgG Test Kit 232580098/79 Captia EBNA-1 IgG Test Kit 232580198/79 Platelia EB-NA-1 IgG Test Kit 7293998/79	– 98/79	EUDAMED record Report an error
Ebv vca igm	W010504040104	Captia EBV-VCA IgM Test Kit 232576098/79 Captia EBV-VCA IgM Test Kit 232576198/79 Platelia EBV-VCA IgM Test Kit 7293698/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Captia H. pylori IgA Test Kit 232643098/79 Captia H. pylori IgG Test Kit 234640098/79 Captia H. pylori IgG Test Kit 234640198/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Bio-Stat Syphilis EIA Test Kit YY6012698/79 Captia Syphilis TA EIA Test Kit 232217098/79 Captia Syphilis TA EIA Test Kit 232217198/79	– 98/79	EUDAMED record Report an error
Cmv igm	W0105040204	Captia™ Cytomegalovirus IgM kit 232526098/79 Captia™ Cytomegalovirus IgM kit 232526198/79	– 98/79	EUDAMED record Report an error
Legionella antibody assays	W0105010502	Bartels Legionella Urinary Antigen Test Kit B1029-44098/79 Captia Legionella pneumophila IgG/IgM Test Kit 234698098/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igg	W0105010303	Captia Syphilis (T. pallidum) IgG Test Kit 800-96098/79 Captia Syphilis (T. pallidum) IgG Test Kit 800-97098/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igm	W0105010304	Captia NMT Syphilis IgM EIA 232936098/79 Syphilis IgM EIA Test Kit 7252098/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	Captia HSV 1 IgM Test Kit 232546098/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	Captia HSV Combined IgM Test Kit 232666098/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	Captia HSV 2 IgM Test Kit 232556098/79	– 98/79	EUDAMED record Report an error

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