AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
2016-09-09
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004493545 | 3004493545 | RANDOX LABORATORIES LIMITED | 1 | N | 2026-01-01 | 36 / 44 LARGY ROAD CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey GB BT29 4RN |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05055273200560 | AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine. | +442894451070 | technical.services@randox.com |
| 05055273200577 | AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine. | +442894451070 | technical.services@randox.com |
| 05055273200584 | AMY - 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. | +442894451070 | technical.services@randox.com |
| 05055273200591 | P 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. | +442894451070 | technical.services@randox.com |
| 05055273200607 | AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine. | +442894451070 | technical.services@randox.com |
| 05055273200614 | P 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. | +442894451070 | technical.services@randox.com |
| 05055273200645 | AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine. | +442894451070 | technical.services@randox.com |
| 05055273200652 | AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine. | +442894451070 | technical.services@randox.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9803 | 1030178974 | K984494 | RANDOX ALBUMIN | CIX | 1999-03-23 |
| 9803 | 1723354791 | K982529 | RANDOX DIRECT LDL CHOLESTEROL | MRR | 1998-09-11 |
| 9803 | 2029138692 | K982341 | DIRECT HDL-CHOLESTROL LIQUID | LBS | 1998-07-30 |
| 9803 | 1894519774 | K974607 | RANDOX CALCIUM | CJY | 1998-02-02 |
| 9803 | 1653053841 | K974606 | RANDOX MAGNESIUM | JGJ | 1998-02-12 |
| 9803 | 1803519196 | K974605 | RANDOX INORGANIC PHOSPHOROUS | CEO | 1998-01-09 |
| 9803 | 1764058041 | K974604 | RANDOX IRON | JMO | 1998-01-06 |
| 9803 | 1687590448 | K973995 | RANDOX BILIRUBIN | GIG | 1997-12-08 |
| 9803 | 1305189110 | K973993 | RANDOX CREATININE | CGX | 1998-03-06 |
| 9803 | 1122590769 | K972608 | RANDOX ASSAYED SPECIFIC PROTEIN CONTROL | JJY | 1997-08-04 |
| 9803 | 1146428148 | K972220 | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT | DHR | 1997-09-09 |
| 9803 | 1095789950 | K971825 | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST | JFJ | 1997-07-24 |
| 9803 | 1617264246 | K970735 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | LBS | 1997-06-06 |
| 9803 | 1563167068 | K970684 | LACTATE DEHYDROGENASE (LD) | CFJ | 1997-05-07 |
| 9803 | 1329484951 | K961169 | RHEUMATOID FACTOR LATEX SLIDE TEST KIT | DHR | 1996-06-26 |
| 9803 | 1362600465 | K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | DEW | 1996-04-05 |
| 9803 | 1095316000 | K955797 | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | DFT | 1996-04-05 |
| 9803 | 1376225420 | K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | CZP | 1996-04-05 |
| 9803 | 2032068830 | K955087 | HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | LCP | 1996-06-13 |
| 9803 | 1901566635 | K954447 | C-REACTIVE PROTEIN LATEX KIT | DCK | 1995-12-18 |
| 9803 | 1412715296 | K953212 | C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR | DCK | 1995-07-31 |
| 9803 | 1998801670 | K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT | CIJ | 1996-06-21 |
| 9803 | 1301549672 | K953210 | GLUCOSE (HEXOKINASE) KIT | CFR | 1996-10-25 |
| 9803 | 1741146475 | K951223 | CK-MB (NAC-ACT) | CGS | 1995-12-26 |
| 9803 | 1431286099 | K951222 | TOTAL PROTEIN (URINE) | JIR | 1996-04-24 |
| 9803 | 1649698631 | K951221 | TOTAL CO2 | KHS | 1996-02-15 |
| 9803 | 1052535471 | K950383 | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | JHN | 1995-09-15 |
| 9803 | 1872776248 | K950382 | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | JHN | 1995-09-15 |
| 9803 | 1975052643 | K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED | JJY | 1995-03-13 |
| 9803 | 1722166384 | K923511 | CK-NAC ACTIVATED KIT | CGS | 1992-10-15 |
| 9803 | 1888295070 | K923510 | ALT (GPT) - ALANINE AMINOTRANSFERASE | CKA | 1992-11-16 |
| 9803 | 1438009303 | K923509 | GAMMA-GT | JPZ | 1992-12-03 |
| 9803 | 2015610211 | K923508 | TRIGLYCERIDES GPO-PAP | CDT | 1993-07-28 |
| 9803 | 1894705124 | K923507 | ALKALINE PHOSPHATASE KIT | CJE | 1992-12-03 |
| 9803 | 1922240135 | K923506 | UREA KIT | CDQ | 1993-09-27 |
| 9803 | 1757492662 | K923505 | AST (GOT) - ASPARTATE AMINOTRANSFERASE | CIT | 1992-11-16 |
| 9803 | 1916029492 | K923504 | CHOLESTEROL ENZYMATIC ENDPOINT | CHH | 1994-01-10 |
| 9803 | 1829702951 | K923503 | URIC ACID ENZYMATIC COLORIMERIC KIT | KNK | 1993-07-22 |
| 9803 | 1282590160 | K882038 | GDS ENZYMATIC SALICYLATE REAGENT | DKJ | 1988-06-24 |
| 9803 | 1976270691 | K881040 | EMIT VANCOMYCIN ASSAY | LEH | 1988-04-19 |
| 9803 | 1678829167 | K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | LDP | 1988-05-27 |
| 9803 | 1195478954 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2026-01-23 |
| 9803 | 1074167777 | K230890 | ISE Electrodes | CEM | 2023-09-08 |
| 9803 | 1890859431 | K221550 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2023-10-05 |
| 9803 | 1182474328 | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | DJG | 2023-10-05 |
| 9803 | 1561782656 | K182042 | Randox Calcium (Ca) | CJY | 2018-10-23 |
| 9803 | 1644883084 | K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | CJE | 2017-04-21 |
| 9803 | 1337192142 | K162200 | Randox RX Daytona Plus Magnesium (MG) | JGJ | 2017-04-28 |
| 9803 | 1320342339 | K161691 | Direct LDL Cholesterol (LDL) | MRR | 2017-03-20 |
| 9803 | 1633183949 | K153435 | Direct HDL Cholesterol (HDL) | LBS | 2016-01-08 |
| 9803 | 1863352776 | K152344 | Total Bilirubin | JFM | 2016-01-28 |
| 9803 | 1945825934 | K152343 | Direct Bilirubin | JFM | 2016-02-16 |
| 9803 | 1973009873 | K152085 | Liquid CO2-2 (LCO2-2) | KHS | 2016-02-24 |
| 9803 | 1948974370 | K150819 | Triglycerides | CDT | 2015-08-06 |
| 9803 | 1212336019 | K150654 | Cholesterol | CHH | 2015-09-29 |
| 9803 | 1019236395 | K142181 | RANDOX ALDOLASE CALIBRATION SERUM | JIT | 2014-09-18 |
| 9803 | 1815870626 | K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | JJY | 2014-12-08 |
| 9803 | 1490278324 | K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | JJY | 2014-05-22 |
| 9803 | 1097634252 | K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | JJY | 2014-03-25 |
| 9803 | 1193913431 | K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | JJY | 2013-10-23 |
| 9803 | 1733458388 | K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | DLJ | 2013-08-08 |
| 9803 | 1076724026 | K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 | JJX | 2013-07-26 |
| 9803 | 1709548611 | K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 | JJX | 2013-07-18 |
| 9803 | 1962659774 | K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | JJE | 2014-01-09 |
| 9803 | 1913405903 | K130337 | RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 | JJY | 2013-06-19 |
| 9803 | 1292573404 | K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | CGS | 2013-11-21 |
| 9803 | 1047871297 | K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | DDR | 2012-10-03 |
| 9803 | 1092894479 | K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | JIS | 2012-08-14 |
| 9803 | 1467335652 | K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) | JJX | 2012-07-11 |
| 9803 | 1225721426 | K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 | JJY | 2012-11-20 |
| 9803 | 1643239443 | K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 | JJX | 2012-06-20 |
| 9803 | 1423967116 | K113751 | RANDOX COCAINE METABOLITE | DIO | 2012-05-08 |
| 9803 | 1234316153 | K113747 | RANDOX OPIATES ASSAY | DJG | 2012-08-24 |
| 9803 | 1164770661 | K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 | JJY | 2012-09-20 |
| 9803 | 1609455830 | K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL | JJY | 2011-12-01 |
| 9803 | 1904388638 | K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 | JJY | 2011-09-30 |
| 9803 | 1271393545 | K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | JJW | 2011-09-30 |
| 9803 | 1410351700 | K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | DBF | 2011-08-17 |
| 9803 | 1835497293 | K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | JJY | 2012-01-23 |
| 9803 | 1264124188 | K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | LCP | 2011-05-17 |
| 9803 | 1377206018 | K103701 | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | JIX | 2011-02-18 |
| 9803 | 1373744677 | K102346 | RANDOX DIGOXIN ASSAY | KXT | 2011-10-14 |
| 9803 | 1791636328 | K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) | JJY | 2010-03-10 |
| 9803 | 1920793747 | K092275 | RANDOX ECSTASY (MDMA) ASSAY | DKZ | 2011-03-01 |
| 9803 | 2017566428 | K092274 | RANDOX BENZODIAZEPINE ASSAY | JXM | 2010-10-15 |
| 9803 | 1040252582 | K092273 | RANDOX ETHANOL ASSAY | DIC | 2010-11-01 |
| 9803 | 1238240249 | K092272 | RANDOX METHADONE ASSAY | DJR | 2010-11-18 |
| 9803 | 1045888514 | K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET | LDJ | 2011-04-08 |
| 9803 | 1363467612 | K092268 | RANDOX BARITURATES ASSAY | DIS | 2011-05-25 |
| 9803 | 1269223922 | K092266 | RANDOX METHAMPHETAMINE ASSAY | DKB | 2011-05-09 |
| 9803 | 1926062281 | K092258 | RANDOX METABOLITE (EDDP) ASSAY | DJR | 2010-11-09 |
| 9803 | 1028956050 | K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | NDY | 2009-03-11 |
| 9803 | 1440120447 | K083386 | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) | CJY | 2009-04-02 |
| 9803 | 1593983966 | K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | LPS | 2009-07-31 |
| 9803 | 1910379448 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | 2008-06-02 |
| 9803 | 1815847769 | K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS | JIX | 2007-10-05 |
| 9803 | 1894422240 | K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | JFM | 2007-12-07 |
| 9803 | 1928786310 | K061056 | RANDOX LIQUID PROTEIN CALIBRATOR | JIX | 2006-07-20 |
| 9803 | 1449799540 | K053153 | RANDOX CALIBRATION SERUM | JIX | 2006-01-13 |
| 9803 | 1050431144 | K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | JFM | 2005-12-30 |
| 9803 | 1207598659 | K052914 | RX IMOLA | CEM | 2006-03-31 |
| 9803 | 1764467669 | K050374 | ADVIA IMS LITHIUM ASSAY | NDW | 2005-06-15 |
| 9803 | 1195296251 | K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY | JXM | 2005-05-17 |
| 9803 | 1819534665 | K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | CEI | 2005-02-15 |
| 9803 | 1698744733 | K043267 | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | CEJ | 2005-02-10 |
| 9803 | 1678726627 | K043266 | RANDOX URINE CONTROLS | JJW | 2005-02-15 |
| 9803 | 1883085181 | K043071 | RANDOX PHENCYCLIDINE ASSAY | LCM | 2005-01-27 |
| 9803 | 1737417363 | K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT | JJX | 2004-10-29 |
| 9803 | 1261347150 | K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM | JJX | 2004-08-16 |
| 9803 | 1568874239 | K041361 | RANDOX TRI LEVEL CARDIAC CONTROL | JJY | 2004-09-09 |
| 9803 | 1035097627 | K041144 | RANDOX OPIATES ASSAY | DJG | 2004-11-03 |
| 9803 | 1399266273 | K041143 | RANDOX BARBITURATE ASSAY | DIS | 2004-11-05 |
| 9803 | 1987306844 | K041142 | RANDOX CANNABINOIDS ASSSAY | LDJ | 2004-11-23 |
| 9803 | 1593612356 | K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS | JJX | 2004-05-17 |
| 9803 | 1604415854 | K040570 | RANDOX METHADONE ASSAY | DJR | 2004-05-10 |
| 9803 | 2051713670 | K040379 | RANDOX IMMUNOASSAY CONTROL | JJY | 2004-06-16 |
| 9803 | 1278758130 | K040351 | RANDOX LIQUID CRP CONTROLS | JJX | 2004-03-12 |
| 9803 | 1920440867 | K040350 | RANDOX AMPHETAMINE CLASS ASSAY | DKZ | 2004-05-12 |
| 9803 | 1864813501 | K033884 | RANDOX AMIKACIN | KLQ | 2004-06-09 |
| 9803 | 1968352543 | K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | JII | 2003-12-23 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JJY | 21 | 2014-12-08 |
| JJX | 8 | 2013-07-26 |
| JIX | 6 | 2011-02-18 |
| DJG | 5 | 2026-01-23 |
| LCP | 5 | 2011-05-17 |
| JFM | 4 | 2016-02-16 |
| CJY | 3 | 2018-10-23 |
| LBS | 3 | 2016-01-08 |
| CGS | 3 | 2013-11-21 |
| JIS | 3 | 2012-08-14 |
| DJR | 3 | 2010-11-18 |
| DCK | 3 | 2000-08-04 |
| CEM | 2 | 2023-09-08 |
| JGJ | 2 | 2017-04-28 |
| CJE | 2 | 2017-04-21 |
| MRR | 2 | 2017-03-20 |
| KHS | 2 | 2016-02-24 |
| CHH | 2 | 2015-09-29 |
| CDT | 2 | 2015-08-06 |
| DDR | 2 | 2012-10-03 |
| DIO | 2 | 2012-05-08 |
| KXT | 2 | 2011-10-14 |
| JJW | 2 | 2011-09-30 |
| DBF | 2 | 2011-08-17 |
| DIS | 2 | 2011-05-25 |
| LDJ | 2 | 2011-04-08 |
| DKZ | 2 | 2011-03-01 |
| JXM | 2 | 2010-10-15 |
| CGA | 2 | 2003-12-04 |
| JIF | 2 | 2003-05-12 |
| JMO | 2 | 2000-05-02 |
| DHR | 2 | 1997-09-09 |
| JHN | 2 | 1995-09-15 |
| SES | 1 | 2025-05-22 |
| JIT | 1 | 2014-09-18 |
| JJE | 1 | 2014-01-09 |
| DLJ | 1 | 2013-08-08 |
| DKB | 1 | 2011-05-09 |
| DIC | 1 | 2010-11-01 |
| LPS | 1 | 2009-07-31 |
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