FDA.reportPublic FDA data

RANDOX LABORATORIES, LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80208903006697287RANDOX LABORATORIES, LTD.1N2020-04-2555 DIAMOND ROAD CRUMLIN Antrim GB BT29 4QY
30066972873006697287RANDOX LABORATORIES, LTD.1N2020-04-2534 DIAMOND RD. CRUMLIN, CO. ANTRIM Antrim GB BT29 4QX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
98021118621972K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMMSJ2000-02-15
405271118621972K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMMSJ2000-02-15
98021000489970K991576ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMCIX1999-06-30
405271000489970K991576ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMCIX1999-06-30
405271030178974K984494RANDOX ALBUMINCIX1999-03-23
98021030178974K984494RANDOX ALBUMINCIX1999-03-23
405271723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
98021723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
405272029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
98022029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
405271894519774K974607RANDOX CALCIUMCJY1998-02-02
98021894519774K974607RANDOX CALCIUMCJY1998-02-02
405271653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
98021653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
405271803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
98021803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
405271764058041K974604RANDOX IRONJMO1998-01-06
98021764058041K974604RANDOX IRONJMO1998-01-06
98021687590448K973995RANDOX BILIRUBINGIG1997-12-08
405271687590448K973995RANDOX BILIRUBINGIG1997-12-08
405271305189110K973993RANDOX CREATININECGX1998-03-06
98021305189110K973993RANDOX CREATININECGX1998-03-06
98021122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
405271122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
405271146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
98021146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
98021095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
405271095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
405271617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
98021617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
405271563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
98021563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
405271329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
98021329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
405271362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
98021362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
405271095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
98021095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
405271376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
98021376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
98022032068830K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSLCP1996-06-13
405272032068830K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSLCP1996-06-13
98021901566635K954447C-REACTIVE PROTEIN LATEX KITDCK1995-12-18
405271901566635K954447C-REACTIVE PROTEIN LATEX KITDCK1995-12-18
405271412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
98021412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
405271998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
98021998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
405271301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
98021301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
98021741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
405271741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
405271431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
98021431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
405271649698631K951221TOTAL CO2KHS1996-02-15
98021649698631K951221TOTAL CO2KHS1996-02-15
405271052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
98021052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
405271872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
98021872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
405271975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
98021975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
405271137537224K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
98021137537224K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
98021722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
405271722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
405271888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
98021888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
405271438009303K923509GAMMA-GTJPZ1992-12-03
98021438009303K923509GAMMA-GTJPZ1992-12-03
405272015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
98022015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
405271894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
98021894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
405271922240135K923506UREA KITCDQ1993-09-27
98021922240135K923506UREA KITCDQ1993-09-27
405271757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
98021757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
405271916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
98021916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
405271829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22
98021829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22
405271282590160K882038GDS ENZYMATIC SALICYLATE REAGENTDKJ1988-06-24
98021282590160K882038GDS ENZYMATIC SALICYLATE REAGENTDKJ1988-06-24
98021976270691K881040EMIT VANCOMYCIN ASSAYLEH1988-04-19
405271976270691K881040EMIT VANCOMYCIN ASSAYLEH1988-04-19
98021678829167K880829GDS ENZYMATIC ACETAMINOPHEN REAGENTLDP1988-05-27
405271678829167K880829GDS ENZYMATIC ACETAMINOPHEN REAGENTLDP1988-05-27
98021832695554K191454Atellica CH Amylase_2 (AMY_2)JFJ2019-07-30
405271832695554K191454Atellica CH Amylase_2 (AMY_2)JFJ2019-07-30
405271561782656K182042Randox Calcium (Ca)CJY2018-10-23
98021561782656K182042Randox Calcium (Ca)CJY2018-10-23
405271413671270K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY2018-05-25
98021413671270K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY2018-05-25
405271777372635K162399Atellica CH Magnesium (Mg)JGJ2017-01-19
98021777372635K162399Atellica CH Magnesium (Mg)JGJ2017-01-19
405271644883084K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE2017-04-21
98021644883084K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE2017-04-21
98021337192142K162200Randox RX Daytona Plus Magnesium (MG)JGJ2017-04-28
405271337192142K162200Randox RX Daytona Plus Magnesium (MG)JGJ2017-04-28
405271320342339K161691Direct LDL Cholesterol (LDL)MRR2017-03-20
98021320342339K161691Direct LDL Cholesterol (LDL)MRR2017-03-20
405271150202672K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX2016-11-15
98021150202672K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX2016-11-15
98021070610203K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS2016-09-07
405271070610203K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS2016-09-07
98021633183949K153435Direct HDL Cholesterol (HDL)LBS2016-01-08
405271633183949K153435Direct HDL Cholesterol (HDL)LBS2016-01-08
405271863352776K152344Total BilirubinJFM2016-01-28
98021863352776K152344Total BilirubinJFM2016-01-28
405271945825934K152343Direct BilirubinJFM2016-02-16
98021945825934K152343Direct BilirubinJFM2016-02-16
405271973009873K152085Liquid CO2-2 (LCO2-2)KHS2016-02-24
98021973009873K152085Liquid CO2-2 (LCO2-2)KHS2016-02-24
405271948974370K150819TriglyceridesCDT2015-08-06
98021948974370K150819TriglyceridesCDT2015-08-06
98021212336019K150654CholesterolCHH2015-09-29
405271212336019K150654CholesterolCHH2015-09-29
405271019236395K142181RANDOX ALDOLASE CALIBRATION SERUMJIT2014-09-18
98021019236395K142181RANDOX ALDOLASE CALIBRATION SERUMJIT2014-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY422014-12-08
JIX182013-01-14
JJX162013-07-26
LCP132014-01-24
CGS82016-09-07
JFM82016-02-16
CJY62018-10-23
JGJ62017-04-28
LBS62016-01-08
CDT62015-08-06
JIS62012-08-14
DJR62010-11-18
CGA62004-09-29
DCK62000-08-04
JFJ42019-07-30
NDY42018-05-25
CJE42017-04-21
MRR42017-03-20
CGX42016-11-15
KHS42016-02-24
CHH42015-09-29
DDR42012-10-03
DJG42012-08-24
DIO42012-05-08
KXT42011-10-14
JJW42011-09-30
DBF42011-08-17
DIS42011-05-25
DKB42011-05-09
LDJ42011-04-08
CFR42011-03-07
DKZ42011-03-01
JXM42010-10-15
JIF42003-05-12
JMO42000-05-02
CIX41999-06-30
DHR41997-09-09
JHN41995-09-15
JIT22014-09-18
JJE22014-01-09

PMN#

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