FDA.reportPublic FDA data

Trinity Biotech USA

Matched from indexed company URL: TRINITY BIOTECH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13183541318354Trinity Biotech USA1Y2026-01-012823 Girts Rd Jamestown NY US 14701
19312511931251Trinity Biotech (Primus Corporation dba Trinity Biotech)1N2026-01-014231 E 75th Ter KANSAS CITY MO US 64132
96815763002546385TRINITY BIOTECH, PLC1N2026-01-01IDA BUSINESS PARK BRAY Wicklow IE --
30320696213032069621Trinity Biotech do Brasil1N2026-01-01Estrada Vereador Lamartine Jose de Oliveira, 1259-A Extrema Minas Gerais BR 37640-000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05391516741927Trinity Biotech - Bile Acids Kit+35312769800Clinicalchemistry.techsupport@
05391516741927Trinity Biotech - Bile Acids Kit+35312769800Clinicalchemistry.techsupport@trinitybiotech.com
05391516742238Trinity Biotech - Oxalate Kit+35312769800Clinicalchemistry.techsupport@
05391516742238Trinity Biotech - Oxalate Kit+35312769800Clinicalchemistry.techsupport@trinitybiotech.com
05391516742245Trinity Biotech - Oxalate Kit+35312769800Clinicalchemistry.techsupport@
05391516742245Trinity Biotech - Oxalate Kit+35312769800Clinicalchemistry.techsupport@trinitybiotech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
163621319373783K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2LCP1999-12-21
163641061687513K993839ENA PROFILE ELISA TEST SYSTEMLLL2000-01-12
163641404533199K992665MACRA LP(A) ENZYME IMMUNOASSAY KITDFC1999-11-26
163641758545764K991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTMJH1999-12-21
163641813184734K980912VCA IGG ELISA TEST SYSTEMLSE1998-07-22
163641650035661K980598EBNA-1 IGM ELISA TEST SYSTEMLLM1998-05-01
163641719548581K980596VCA IGM ELISA TEST SYSTEMLSE1998-07-22
163641767723023K973123EA-D IGG ELISA TEST SYSTEMLSE1998-03-26
163641437676988K972041EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)LBS1997-07-22
163641520592648K971157MACRALP(A) ENZYME IMMUNOASSAY KITJHO1998-04-15
163641191595535K961765MPO ELISA TEST SYSTEMMOB1996-08-19
163641567913304K961764PR-3 ELISA TEST SYSTEMMOB1996-08-19
163621046009633K955283PRIMUS VARIANT SYSTEM PVS99GKA1996-03-01
163641565093667K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
163641101304571K951549EBNA IGG EIA TEST SYSTEMLLM1996-04-29
163641996011327K941358THYROGLOBULIN EIA TEST KITJNL1994-05-11
163641607396835K941085LIPASE-PS ASSAY PROCEDURE NO. 805CHI1994-05-17
163641843540579K940253HISTONE EIA TEST KITLJM1994-05-02
163641588336284K940251MITOCHONDRIA EIA TEST KITDBM1994-05-03
163641347267266K935987FLEXTRANSJSM1994-08-15
163641907716506K935419LA EIA TEST KITLLL1994-05-05
163641634947024K935418SCL-70 EIA TEST KITLLL1994-05-05
163641690777979K935417JO-1 EIA TEST KITLLL1994-05-05
163642024286789K935416RO EIA TEST KITLJM1994-05-02
163641034897800K935415RNP EIA TEST KITLJM1994-05-02
163641848306192K935414SM EIA TEST KITLJM1994-05-02
163641024704078K935413ENA EIA TEST KITLLL1994-06-02
520751589839524K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-AJBF1995-06-29
163641453896116K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJIS1993-06-07
163641488381151K924056ENCORE RHEUMATOID FACTOR EIADHR1992-09-25
163641953073434K923537ENCORE DS-DNALRM1992-12-23
163641726528399K921573RUBELLA IGMLFX1992-08-27
163641790736294K921011PHARMACIA CMV IGM ELISALFZ1992-07-27
163641812222700K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOLGD1992-07-08
163641555432934K914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSLFY1992-01-27
163641037402823K904524CAPTIA(R) SYPHILIS M, MODIFICATIONLIP1990-12-26
163642053819643K897006PHARMACIA MUMPS IGG ELISALJY1990-07-26
163641042921214K896295CAPTIA(R) CMV-MLFZ1990-03-06
163641295614624K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEMLSR1989-08-21
163641309408099K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEMLSR1989-08-21
163642051664294K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEMLSR1989-08-15
163621990134754K891235PRIMUS MODEL CLC 330LCP1989-06-16
163641764736214K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIGNP1989-04-28
520751663790335K883525OXALATE REAGENTLPW1988-10-25
163641949027254K883427VIRGO(R) VZV-IGG ELISAGQX1989-03-10
163641550975434K883282VIRGO HSV-1 IGG ELISAGQO1989-03-10
163641716731531K883281VIRGO HSV-2 IGG ELISAGQO1989-03-10
163641826870887K883102VIRGO (R) CMV-IGG ELISAGQI1989-02-08
163641198832984K873925VIRGO(TM) MEASLES IGG ELISALJB1988-02-24
520751852466546K873342BILE ACIDS CONTROLSJJX1987-10-20
163641663864366K873088VIRGO(TM) RUBELLA IGG ELISALFX1987-09-09
520751763197355K872451BILE ACIDS CALIBRATORJIT1987-08-21
520751453096161K872296BILE ACIDS REAGENTKWW1987-08-26
163641468761291K871905TOXOPLASMA GONDII IGG ELISALGD1987-07-30
163641061723574K860453ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040JJX1986-02-19
520751895816954K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVKQN1986-01-22
520751499334450K842366OXALATE URINE CONTROLS NORMAL & ELEVATJJW1984-09-12
163641151471284K834136PBS W/MG+2 & CA+2KIT1984-03-22
163641759903186K834125CHLAMYDIAL TRANSPORT MEDIUMJSM1984-02-13
163641858069849K834122CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEXKIT1984-02-13
163641439920134K834116DEAE-DEXTRAN IN PBSKIT1984-04-20
163641160780246K834115CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUTJSK1984-03-23
163641800507792K834113TISSUE CULTURE REFEEDING MEDIUMKIT1984-03-23
163641999065592K802568HEMOGLOBIN CONTROLKHG1980-11-12
520751201924772K790211DEHYDROGENOSE, GLUCOSE PHOSPHATEJBL1979-03-15
163621609071391K222635Premier Resolution SystemGKA2023-08-04
163641269716767K140455CAPTIA MEASLES IGMPCL2014-05-22
163621114133121K112015PREMIER HB9210 HBA1C ANALYZERLCP2011-11-22
163621700129461K062658PRIMUS A1CARE ASSAYLCP2007-11-26
163641578332540K033106CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KITMYF2004-07-13
163641970726467K033105CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KITMXJ2004-07-13
163641283945207K033083BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMLSR2003-11-26
163641248457786K033079CHLAMYDIA IGG ELISA TEST SYSTEMLJC2003-11-26
163641526855416K033067PYLORI IGGLYR2003-11-26
163641486141180K033064MYCOPLASMA IGGLON2003-11-26
163641203625254K033059HERPES GROUP IGGLGC2003-11-26
163641585617071K033051LEGIONELLA PNEUMOPHILA IGG/IGMMJH2003-11-26
163641078618671K014233CAPTIAM SYPHILIS-G ASSAYLIP2002-01-24
163641321689562K001552TREPCHEK TREPONEMAL ANTIBODY EIALIP2000-10-19
163641033750027K001005WAKO HDL-C/LDL-C CALIBRATORJIS2000-06-01
520751942281819BP030025
520751735875188BK120021
163641021578104
163641005485350
163641055858852
163641078242723
163621087202682
3349161114133121
163641192004581
520751238670299
163641274423162
163621300202185
520751347267266
163641380118613
163641385323424
520751466073559
520751573696518
520751608213652
3349161609071391
163641750276021
520751838286270
163641936842104
163641937898831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLL52000-01-12
LCP42011-11-22
LSR42003-11-26
LJM41994-05-02
KIT41984-04-20
LIP32002-01-24
LSE31998-07-22
GKA22023-08-04
MJH22003-11-26
JIS22000-06-01
LLM21998-05-01
MOB21996-08-19
JSM21994-08-15
LFX21992-08-27
LFZ21992-07-27
LGD21992-07-08
GQO21989-03-10
JJX21987-10-20
PCL12014-05-22
MXJ12004-07-13
MYF12004-07-13
LJC12003-11-26
LGC12003-11-26
LON12003-11-26
LYR12003-11-26
DFC11999-11-26
JHO11998-04-15
LBS11997-07-22
LKJ11995-12-15
JBF11995-06-29
CHI11994-05-17
JNL11994-05-11
DBM11994-05-03
LRM11992-12-23
DHR11992-09-25
LFY11992-01-27
LJY11990-07-26
GNP11989-04-28
GQX11989-03-10
GQI11989-02-08

PMN#

GUDID#

49 records. Showing 1-40. Next