Manufacturer's Devices - Acon Laboratories Inc.

Address:




5850 Oberlin Drive #340



San Diego CA

92121

United States


Authorised Representative/ UK Responsible Person
Name: MDSS-UK RP LIMITED
Address:

6 Wilmslow Road Rusholme



Manchester

M14 5TP

England United Kingdom




Code/Term Type
Fluorescent immunoassay analyser IVD point-of-care line-poweredFluorescent immunoassay analyser IVD point-of-care line-poweredIVD General
Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automatedThermal cycler nucleic acid amplification analyser IVD laboratory semi-automatedIVD General
Blood lancet single-useBlood lancet single-useClass IIa
Manual blood lancing device reusableManual blood lancing device reusableClass I
Triglyceride IVD kit enzyme spectrophotometryTriglyceride IVD kit enzyme spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD controlHigh density lipoprotein (HDL) cholesterol IVD controlIVD General
Total cholesterol lipid IVD controlTotal cholesterol lipid IVD controlIVD General
Triglyceride IVD controlTriglyceride IVD controlIVD General
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD General
Uric acid IVD controlUric acid IVD controlIVD General
Glucose/ketone/lipid profile IVD controlGlucose/ketone/lipid profile IVD controlIVD General
Uric acid monitoring system IVD home-useUric acid monitoring system IVD home-useIVD General
Glucose/ketone monitoring system IVD home-useGlucose/ketone monitoring system IVD home-useIVD General
Total haemoglobin (totHb) IVD controlTotal haemoglobin (totHb) IVD controlIVD General
Haemoglobin detection IVD controlHaemoglobin detection IVD controlIVD General
Haemoglobin/hematocrit IVD kit electrometryHaemoglobin/hematocrit IVD kit electrometryIVD General
Haemoglobin/hematocrit analyser IVDHaemoglobin/hematocrit analyser IVDIVD General
Coagulation factor II (prothrombin) IVD controlCoagulation factor II (prothrombin) IVD controlIVD General
Coagulation factor II (prothrombin) IVD kit chromogenicCoagulation factor II (prothrombin) IVD kit chromogenicIVD General
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD General
Urine blood IVD kit rapid colorimetric clinicalUrine blood IVD kit rapid colorimetric clinicalIVD General
Urine bilirubin IVD kit rapid colorimetric clinicalUrine bilirubin IVD kit rapid colorimetric clinicalIVD General
Urine creatinine IVD kit rapid colorimetric clinicalUrine creatinine IVD kit rapid colorimetric clinicalIVD General
Urine glucose IVD kit rapid colorimetric clinicalUrine glucose IVD kit rapid colorimetric clinicalIVD General
Urine ketone IVD kit rapid colorimetric clinicalUrine ketone IVD kit rapid colorimetric clinicalIVD General
Urine leukocyte IVD kit rapid colorimetric clinicalUrine leukocyte IVD kit rapid colorimetric clinicalIVD General
Urine nitrite IVD kit rapid colorimetric clinicalUrine nitrite IVD kit rapid colorimetric clinicalIVD General
Urine pH IVD kit rapid colorimetric clinicalUrine pH IVD kit rapid colorimetric clinicalIVD General
Urine protein IVD kit rapid colorimetric clinicalUrine protein IVD kit rapid colorimetric clinicalIVD General
Urine specific gravity IVD kit rapid colorimetric clinicalUrine specific gravity IVD kit rapid colorimetric clinicalIVD General
Urine urobilinogen IVD kit rapid colorimetric clinicalUrine urobilinogen IVD kit rapid colorimetric clinicalIVD General
Urine albumin IVD kit rapid colorimetric clinicalUrine albumin IVD kit rapid colorimetric clinicalIVD General
Multiple urine analyte IVD controlMultiple urine analyte IVD controlIVD General
High density lipoprotein (HDL) cholesterol IVD controlHigh density lipoprotein (HDL) cholesterol IVD controlIVD Devices for Self-Testing
Coagulation factor II (prothrombin) IVD controlCoagulation factor II (prothrombin) IVD controlIVD Devices for Self-Testing
Coagulation factor II (prothrombin) IVD kit chromogenicCoagulation factor II (prothrombin) IVD kit chromogenicIVD Devices for Self-Testing
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine blood IVD kit rapid colorimetric clinicalUrine blood IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine bilirubin IVD kit rapid colorimetric clinicalUrine bilirubin IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine glucose IVD kit rapid colorimetric clinicalUrine glucose IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine ketone IVD kit rapid colorimetric clinicalUrine ketone IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine leukocyte IVD kit rapid colorimetric clinicalUrine leukocyte IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine nitrite IVD kit rapid colorimetric clinicalUrine nitrite IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine pH IVD kit rapid colorimetric clinicalUrine pH IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine protein IVD kit rapid colorimetric clinicalUrine protein IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine specific gravity IVD kit rapid colorimetric clinicalUrine specific gravity IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Glucose/ketone monitoring system IVD home-useGlucose/ketone monitoring system IVD home-useIVD Devices for Self-Testing
Glucose/ketone monitoring system IVD home-useGlucose/ketone monitoring system IVD home-useIVD Annex II List B
Total cholesterol lipid IVD controlTotal cholesterol lipid IVD controlIVD Devices for Self-Testing
Triglyceride IVD controlTriglyceride IVD controlIVD Devices for Self-Testing
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD Devices for Self-Testing
Triglyceride IVD kit enzyme spectrophotometryTriglyceride IVD kit enzyme spectrophotometryIVD Devices for Self-Testing
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Uric acid IVD controlUric acid IVD controlIVD Devices for Self-Testing
Glucose/ketone/lipid profile IVD controlGlucose/ketone/lipid profile IVD controlIVD Devices for Self-Testing
Uric acid monitoring system IVD home-useUric acid monitoring system IVD home-useIVD Devices for Self-Testing
Urine urobilinogen IVD kit rapid colorimetric clinicalUrine urobilinogen IVD kit rapid colorimetric clinicalIVD Devices for Self-Testing
Urine analyser IVD laboratory semi-automatedUrine analyser IVD laboratory semi-automatedClass A
Glucose IVD controlGlucose IVD controlIVD General
Glucose IVD controlGlucose IVD controlIVD Annex II List B
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD Annex II List B
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD Devices for Self-Testing