Manufacturer's Devices - ARKRAY Factory Inc.

Address:




1480 Koji Konan-cho

Koka-shi

Shiga

520-3306

Japan


Authorised Representative/ UK Responsible Person
Name: Arkray Ltd
Address:

Beacon House Ibstone Road

Stokenchurch Business Park

High Wycombe

Buckinghamshire HP14 3FE

England United Kingdom




Code/Term Type
Lactate electrode IVDLactate electrode IVDIVD Devices for Self-Testing
Lactate analyser IVD point-of-careLactate analyser IVD point-of-careIVD Devices for Self-Testing
Ammonia IVD kit spectrophotometryAmmonia IVD kit spectrophotometryIVD General
Cell morphology analyser IVD automated/semi-automatedCell morphology analyser IVD automated/semi-automatedIVD General
Urine sediment IVD calibratorUrine sediment IVD calibratorIVD General
Urine sediment IVD controlUrine sediment IVD controlIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
Biological stain IVDBiological stain IVDIVD General
Multiple urine analyte IVD controlMultiple urine analyte IVD controlIVD General
Urine specific gravity IVD kit rapid colorimetric clinicalUrine specific gravity IVD kit rapid colorimetric clinicalIVD General
Glycated haemoglobin (HbA1c) IVD reagentGlycated haemoglobin (HbA1c) IVD reagentIVD General
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Uric acid IVD kit enzyme spectrophotometryUric acid IVD kit enzyme spectrophotometryIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
Triglyceride IVD kit enzyme spectrophotometryTriglyceride IVD kit enzyme spectrophotometryIVD General
Urea IVD kit enzyme spectrophotometryUrea IVD kit enzyme spectrophotometryIVD General
Total bilirubin IVD kit spectrophotometryTotal bilirubin IVD kit spectrophotometryIVD General
Total protein IVD kit enzyme spectrophotometryTotal protein IVD kit enzyme spectrophotometryIVD General
Albumin IVD kit enzyme spectrophotometryAlbumin IVD kit enzyme spectrophotometryIVD General
Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryTotal aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryIVD General
Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometryAlanine aminotransferase (ALT) IVD kit enzyme spectrophotometryIVD General
Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryTotal lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryIVD General
Total amylase IVD kit enzyme spectrophotometryTotal amylase IVD kit enzyme spectrophotometryIVD General
Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryGamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryIVD General
Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryTotal alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryIVD General
Fructosamine IVD kit enzyme spectrophotometryFructosamine IVD kit enzyme spectrophotometryIVD General
Inorganic phosphate (PO43-) IVD kit spectrophotometryInorganic phosphate (PO43-) IVD kit spectrophotometryIVD General
Magnesium (Mg2+) IVD kit spectrophotometryMagnesium (Mg2+) IVD kit spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Multiple electrolyte IVD controlMultiple electrolyte IVD controlIVD General
Total creatine kinase (CK) IVD kit enzyme spectrophotometryTotal creatine kinase (CK) IVD kit enzyme spectrophotometryIVD General
Glycated haemoglobin (HbA1c) IVD calibratorGlycated haemoglobin (HbA1c) IVD calibratorIVD General
C-reactive protein (CRP) IVD kit nephelometry/turbidimetryC-reactive protein (CRP) IVD kit nephelometry/turbidimetryIVD General
Multiple electrolyte IVD kit ion-selective electrode (ISE)Multiple electrolyte IVD kit ion-selective electrode (ISE)IVD General
Osmometric analyser IVDOsmometric analyser IVDIVD General
Urine analyser IVD laboratoryUrine analyser IVD laboratoryIVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD Annex II List B
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD General
Creatinine IVD kit enzyme spectrophotometryCreatinine IVD kit enzyme spectrophotometryIVD General
Multiple clinical chemistry enzyme IVD kit enzyme spectrophotometryMultiple clinical chemistry enzyme IVD kit enzyme spectrophotometryIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Osmolality IVD controlOsmolality IVD controlIVD General
Clinical laboratory analyser/instrument control unit IVDClinical laboratory analyser/instrument control unit IVDClass A
Nephelometry immunoassay analyser IVD semi-automatedNephelometry immunoassay analyser IVD semi-automatedClass A
Multichannel clinical chemistry analyser IVD laboratoryMultichannel clinical chemistry analyser IVD laboratoryClass A
Single-channel clinical chemistry analyser IVD point-of-careSingle-channel clinical chemistry analyser IVD point-of-careClass A
Glycated haemoglobin (HbA1c) IVD kit liquid chromatographyGlycated haemoglobin (HbA1c) IVD kit liquid chromatographyClass A
High performance liquid chromatography analyser column IVDHigh performance liquid chromatography analyser column IVDClass A
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlClass A
Glycated haemoglobin (HbA1C) analyser IVDGlycated haemoglobin (HbA1C) analyser IVDClass A
pH-adjusted buffer solution IVDpH-adjusted buffer solution IVDClass A
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemClass A
Urine analyser IVD laboratory semi-automatedUrine analyser IVD laboratory semi-automatedClass A
Urine analyser IVD point-of-careUrine analyser IVD point-of-careClass A
Ion-selective analyser IVD semi-automatedIon-selective analyser IVD semi-automatedClass A
Non-evacuated blood collection tube IVD anticoagulant/separatorNon-evacuated blood collection tube IVD anticoagulant/separatorClass A
Single-channel clinical chemistry analyser IVD point-of-careSingle-channel clinical chemistry analyser IVD point-of-careIVD General
Urine analyser IVD point-of-careUrine analyser IVD point-of-careIVD General
Urine analyser IVD laboratory semi-automatedUrine analyser IVD laboratory semi-automatedIVD General
Multichannel clinical chemistry analyser IVD laboratoryMultichannel clinical chemistry analyser IVD laboratoryIVD General
Nephelometry immunoassay analyser IVD semi-automatedNephelometry immunoassay analyser IVD semi-automatedIVD General
Clinical laboratory analyser/instrument control unit IVDClinical laboratory analyser/instrument control unit IVDIVD General
Glycated haemoglobin (HbA1C) analyser IVDGlycated haemoglobin (HbA1C) analyser IVDIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
High performance liquid chromatography analyser column IVDHigh performance liquid chromatography analyser column IVDIVD General
Ion-selective analyser IVD semi-automatedIon-selective analyser IVD semi-automatedIVD General
pH-adjusted buffer solution IVDpH-adjusted buffer solution IVDIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Glycated haemoglobin (HbA1c) IVD kit liquid chromatographyGlycated haemoglobin (HbA1c) IVD kit liquid chromatographyIVD General