FDA.reportPublic FDA data

RANDOX LABORATORIES-US, LTD

Matched from indexed company URL: Randox Laboratories Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20869933003059701RANDOX LABORATORIES-US, LTD1Y2026-01-01515 INDUSTRIAL BOULEVARD JEFFERSON COUNTY Kearneysville WV US 25430
30044935453004493545RANDOX LABORATORIES LIMITED1N2026-01-0136 / 44 LARGY ROAD CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey GB BT29 4RN
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

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
05055273200584AMY - The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of amylase activity in serum, plasma and urine.+442894451070technical.services@randox.com
05055273200591P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.+442894451070technical.services@randox.com
05055273200607AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.+442894451070technical.services@randox.com
05055273200614P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.+442894451070technical.services@randox.com
05055273200645AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.+442894451070technical.services@randox.com
05055273200652AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.+442894451070technical.services@randox.com
05055273200669P AMY - The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.+442894451070technical.services@randox.com
05055273200676AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.+442894451070technical.services@randox.com

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
98021030178974K984494RANDOX ALBUMINCIX1999-03-23
98031030178974K984494RANDOX ALBUMINCIX1999-03-23
405271030178974K984494RANDOX ALBUMINCIX1999-03-23
98021723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
98031723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
405271723354791K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
98022029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
98032029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
405272029138692K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
98021894519774K974607RANDOX CALCIUMCJY1998-02-02
98031894519774K974607RANDOX CALCIUMCJY1998-02-02
405271894519774K974607RANDOX CALCIUMCJY1998-02-02
98021653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
98031653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
405271653053841K974606RANDOX MAGNESIUMJGJ1998-02-12
98021803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
98031803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
405271803519196K974605RANDOX INORGANIC PHOSPHOROUSCEO1998-01-09
98021764058041K974604RANDOX IRONJMO1998-01-06
98031764058041K974604RANDOX IRONJMO1998-01-06
405271764058041K974604RANDOX IRONJMO1998-01-06
98021687590448K973995RANDOX BILIRUBINGIG1997-12-08
98031687590448K973995RANDOX BILIRUBINGIG1997-12-08
405271687590448K973995RANDOX BILIRUBINGIG1997-12-08
98021305189110K973993RANDOX CREATININECGX1998-03-06
98031305189110K973993RANDOX CREATININECGX1998-03-06
405271305189110K973993RANDOX CREATININECGX1998-03-06
98021122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
98031122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
405271122590769K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROLJJY1997-08-04
98021146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
98031146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
405271146428148K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITDHR1997-09-09
98021095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
98031095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
405271095789950K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TESTJFJ1997-07-24
98021617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
98031617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
405271617264246K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1997-06-06
98021563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
98031563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
405271563167068K970684LACTATE DEHYDROGENASE (LD)CFJ1997-05-07
98021329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
98031329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
405271329484951K961169RHEUMATOID FACTOR LATEX SLIDE TEST KITDHR1996-06-26
98021362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
98031362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
405271362600465K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORDEW1996-04-05
98021095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
98031095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
405271095316000K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORDFT1996-04-05
98021376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
98031376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
405271376225420K955794IGA IMMUNOTURBIDIMETRIC & CALIBRATORCZP1996-04-05
98022032068830K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSLCP1996-06-13
98032032068830K955087HEMOGLOBIN 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
98031901566635K954447C-REACTIVE PROTEIN LATEX KITDCK1995-12-18
405271901566635K954447C-REACTIVE PROTEIN LATEX KITDCK1995-12-18
98021412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
98031412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
405271412715296K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCK1995-07-31
98021998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
98031998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
405271998801670K953211AMYLASE (ETHYLIDENE PNGPG7) KITCIJ1996-06-21
98021301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
98031301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
405271301549672K953210GLUCOSE (HEXOKINASE) KITCFR1996-10-25
98021741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
98031741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
405271741146475K951223CK-MB (NAC-ACT)CGS1995-12-26
98021431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
98031431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
405271431286099K951222TOTAL PROTEIN (URINE)JIR1996-04-24
98021649698631K951221TOTAL CO2KHS1996-02-15
98031649698631K951221TOTAL CO2KHS1996-02-15
405271649698631K951221TOTAL CO2KHS1996-02-15
98021052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
98031052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
405271052535471K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITJHN1995-09-15
98021872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
98031872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
405271872776248K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITJHN1995-09-15
98021975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
98031975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
405271975052643K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
98021137537224K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
405271137537224K930104ACE CLINICAL CHEMISTRY SYSTEMJIX1993-08-23
98021722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
98031722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
405271722166384K923511CK-NAC ACTIVATED KITCGS1992-10-15
98021888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
98031888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
405271888295070K923510ALT (GPT) - ALANINE AMINOTRANSFERASECKA1992-11-16
98021438009303K923509GAMMA-GTJPZ1992-12-03
98031438009303K923509GAMMA-GTJPZ1992-12-03
405271438009303K923509GAMMA-GTJPZ1992-12-03
98022015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
98032015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
405272015610211K923508TRIGLYCERIDES GPO-PAPCDT1993-07-28
98021894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
98031894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
405271894705124K923507ALKALINE PHOSPHATASE KITCJE1992-12-03
98021922240135K923506UREA KITCDQ1993-09-27
98031922240135K923506UREA KITCDQ1993-09-27
405271922240135K923506UREA KITCDQ1993-09-27
98021757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
98031757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
405271757492662K923505AST (GOT) - ASPARTATE AMINOTRANSFERASECIT1992-11-16
98021916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
98031916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
405271916029492K923504CHOLESTEROL ENZYMATIC ENDPOINTCHH1994-01-10
98021829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22
98031829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22
405271829702951K923503URIC ACID ENZYMATIC COLORIMERIC KITKNK1993-07-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY632014-12-08
JJX242013-07-26
JIX242013-01-14
LCP182014-01-24
JFM122016-02-16
CGS112016-09-07
DJG92026-01-23
CJY92018-10-23
LBS92016-01-08
JIS92012-08-14
DJR92010-11-18
DCK92000-08-04
JGJ82017-04-28
CDT82015-08-06
CGA82004-09-29
CJE62017-04-21
MRR62017-03-20
KHS62016-02-24
CHH62015-09-29
DDR62012-10-03
DIO62012-05-08
KXT62011-10-14
JJW62011-09-30
DBF62011-08-17
DIS62011-05-25
DKB62011-05-09
LDJ62011-04-08
DKZ62011-03-01
JXM62010-10-15
JIF62003-05-12
JMO62000-05-02
DHR61997-09-09
JHN61995-09-15
JFJ52019-07-30
NDY52018-05-25
CGX52016-11-15
CFR52011-03-07
CIX51999-06-30
CEM42023-09-08
JIT32014-09-18

PMN#

131 records. Showing 1-40. Next

GUDID#

BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit - The Baseline Self-Draw (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.

RANDOX LABORATORIES LIMITED

2026-05-22

80 records. Showing 1-40. Next