Trinity Biotech USA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1318354	1318354	Trinity Biotech USA	1	Y	2026-01-01	2823 Girts Rd Jamestown NY US 14701

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
16364	1061687513	K993839	ENA PROFILE ELISA TEST SYSTEM	LLL	2000-01-12
16364	1404533199	K992665	MACRA LP(A) ENZYME IMMUNOASSAY KIT	DFC	1999-11-26
16364	1758545764	K991074	BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST	MJH	1999-12-21
16364	1813184734	K980912	VCA IGG ELISA TEST SYSTEM	LSE	1998-07-22
16364	1650035661	K980598	EBNA-1 IGM ELISA TEST SYSTEM	LLM	1998-05-01
16364	1719548581	K980596	VCA IGM ELISA TEST SYSTEM	LSE	1998-07-22
16364	1767723023	K973123	EA-D IGG ELISA TEST SYSTEM	LSE	1998-03-26
16364	1437676988	K972041	EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)	LBS	1997-07-22
16364	1520592648	K971157	MACRALP(A) ENZYME IMMUNOASSAY KIT	JHO	1998-04-15
16364	1191595535	K961765	MPO ELISA TEST SYSTEM	MOB	1996-08-19
16364	1567913304	K961764	PR-3 ELISA TEST SYSTEM	MOB	1996-08-19
16364	1565093667	K954723	ENZYME IMMUNOASSAY ANA SCREENING TEST KIT	LKJ	1995-12-15
16364	1101304571	K951549	EBNA IGG EIA TEST SYSTEM	LLM	1996-04-29
16364	1996011327	K941358	THYROGLOBULIN EIA TEST KIT	JNL	1994-05-11
16364	1607396835	K941085	LIPASE-PS ASSAY PROCEDURE NO. 805	CHI	1994-05-17
16364	1843540579	K940253	HISTONE EIA TEST KIT	LJM	1994-05-02
16364	1588336284	K940251	MITOCHONDRIA EIA TEST KIT	DBM	1994-05-03
16364	1347267266	K935987	FLEXTRANS	JSM	1994-08-15
16364	1907716506	K935419	LA EIA TEST KIT	LLL	1994-05-05
16364	1634947024	K935418	SCL-70 EIA TEST KIT	LLL	1994-05-05
16364	1690777979	K935417	JO-1 EIA TEST KIT	LLL	1994-05-05
16364	2024286789	K935416	RO EIA TEST KIT	LJM	1994-05-02
16364	1034897800	K935415	RNP EIA TEST KIT	LJM	1994-05-02
16364	1848306192	K935414	SM EIA TEST KIT	LJM	1994-05-02
16364	1024704078	K935413	ENA EIA TEST KIT	LLL	1994-06-02
16364	1453896116	K930477	ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR	JIS	1993-06-07
16364	1488381151	K924056	ENCORE RHEUMATOID FACTOR EIA	DHR	1992-09-25
16364	1953073434	K923537	ENCORE DS-DNA	LRM	1992-12-23
16364	1726528399	K921573	RUBELLA IGM	LFX	1992-08-27
16364	1790736294	K921011	PHARMACIA CMV IGM ELISA	LFZ	1992-07-27
16364	1812222700	K920702	TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO	LGD	1992-07-08
16364	1555432934	K914022	SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS	LFY	1992-01-27
16364	1037402823	K904524	CAPTIA(R) SYPHILIS M, MODIFICATION	LIP	1990-12-26
16364	2053819643	K897006	PHARMACIA MUMPS IGG ELISA	LJY	1990-07-26
16364	1042921214	K896295	CAPTIA(R) CMV-M	LFZ	1990-03-06
16364	1295614624	K894293	MARDX LYME DISEASE EIA (IGM) TEST SYSTEM	LSR	1989-08-21
16364	1309408099	K894224	MARDX LYME DISEASE EIA (IGG) TEST SYSTEM	LSR	1989-08-21
16364	2051664294	K892206	MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM	LSR	1989-08-15
16364	1764736214	K883670	SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI	GNP	1989-04-28
16364	1949027254	K883427	VIRGO(R) VZV-IGG ELISA	GQX	1989-03-10
16364	1550975434	K883282	VIRGO HSV-1 IGG ELISA	GQO	1989-03-10
16364	1716731531	K883281	VIRGO HSV-2 IGG ELISA	GQO	1989-03-10
16364	1826870887	K883102	VIRGO (R) CMV-IGG ELISA	GQI	1989-02-08
16364	1198832984	K873925	VIRGO(TM) MEASLES IGG ELISA	LJB	1988-02-24
16364	1663864366	K873088	VIRGO(TM) RUBELLA IGG ELISA	LFX	1987-09-09
16364	1468761291	K871905	TOXOPLASMA GONDII IGG ELISA	LGD	1987-07-30
16364	1061723574	K860453	ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040	JJX	1986-02-19
16364	1151471284	K834136	PBS W/MG+2 & CA+2	KIT	1984-03-22
16364	1759903186	K834125	CHLAMYDIAL TRANSPORT MEDIUM	JSM	1984-02-13
16364	1858069849	K834122	CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX	KIT	1984-02-13
16364	1439920134	K834116	DEAE-DEXTRAN IN PBS	KIT	1984-04-20
16364	1160780246	K834115	CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT	JSK	1984-03-23
16364	1800507792	K834113	TISSUE CULTURE REFEEDING MEDIUM	KIT	1984-03-23
16364	1999065592	K802568	HEMOGLOBIN CONTROL	KHG	1980-11-12
16364	1269716767	K140455	CAPTIA MEASLES IGM	PCL	2014-05-22
16364	1578332540	K033106	CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT	MYF	2004-07-13
16364	1970726467	K033105	CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT	MXJ	2004-07-13
16364	1283945207	K033083	BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM	LSR	2003-11-26
16364	1248457786	K033079	CHLAMYDIA IGG ELISA TEST SYSTEM	LJC	2003-11-26
16364	1526855416	K033067	PYLORI IGG	LYR	2003-11-26
16364	1486141180	K033064	MYCOPLASMA IGG	LON	2003-11-26
16364	1203625254	K033059	HERPES GROUP IGG	LGC	2003-11-26
16364	1585617071	K033051	LEGIONELLA PNEUMOPHILA IGG/IGM	MJH	2003-11-26
16364	1078618671	K014233	CAPTIAM SYPHILIS-G ASSAY	LIP	2002-01-24
16364	1321689562	K001552	TREPCHEK TREPONEMAL ANTIBODY EIA	LIP	2000-10-19
16364	1033750027	K001005	WAKO HDL-C/LDL-C CALIBRATOR	JIS	2000-06-01
16364	1021578104
16364	1005485350
16364	1055858852
16364	1078242723
16364	1192004581
16364	1274423162
16364	1380118613
16364	1385323424
16364	1750276021
16364	1936842104
16364	1937898831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LLL	5	2000-01-12
LSR	4	2003-11-26
LJM	4	1994-05-02
KIT	4	1984-04-20
LIP	3	2002-01-24
LSE	3	1998-07-22
MJH	2	2003-11-26
JIS	2	2000-06-01
LLM	2	1998-05-01
MOB	2	1996-08-19
JSM	2	1994-08-15
LFX	2	1992-08-27
LFZ	2	1992-07-27
LGD	2	1992-07-08
GQO	2	1989-03-10
PCL	1	2014-05-22
MYF	1	2004-07-13
MXJ	1	2004-07-13
LON	1	2003-11-26
LGC	1	2003-11-26
LYR	1	2003-11-26
LJC	1	2003-11-26
DFC	1	1999-11-26
JHO	1	1998-04-15
LBS	1	1997-07-22
LKJ	1	1995-12-15
CHI	1	1994-05-17
JNL	1	1994-05-11
DBM	1	1994-05-03
LRM	1	1992-12-23
DHR	1	1992-09-25
LFY	1	1992-01-27
LJY	1	1990-07-26
GNP	1	1989-04-28
GQX	1	1989-03-10
GQI	1	1989-02-08
LJB	1	1988-02-24
JJX	1	1986-02-19
JSK	1	1984-03-23
KHG	1	1980-11-12