Blood Glucose/Blood Ketone/Uric Acid/Blood Lipids Test Kit (Electrochemical and Dry Chemistry Methods)

Trade name

Blood Glucose/Blood Ketone/Uric Acid/Blood Lipids Test Kit (Electrochemical and Dry Chemistry Methods)

UDI-DI code

06977981880164

Basic UDI-DI

B-06977981880164

Reference / catalog number

AA1401

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This kit is intended for the in vitro quantitative determination of concentrations of blood glucose (GLU), blood ketone (β-HB), uric acid (UA), total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) in human venous whole blood, serum, plasma, and upper-arm peripheral whole blood samples. This product is suitable for testing by professional medical personnel in medical institutions. GLU is clinically used as an aid in reflecting blood glucose and urine glucose levels and in the diagnosis of glucose metabolism disorders. β-HB is clinically used as an aid in the diagnosis of ketoacidosis. UA is clinically used to assist in the diagnosis of hyperuricemia. TC is clinically used to assist in the diagnosis of hypercholesterolemia. TG is clinically used to assist in the diagnosis of hypertriglyceridemia, atherosclerosis, and coronary heart disease. HDL-C is clinically used to assist in the diagnosis of hypercholesterolemia, coronary heart disease, and atherosclerosis. Combined testing of GLU, β-HB, UA, TC, TG, and HDL-C is used as an aid in reflecting blood glucose levels and in the diagnosis of glucose metabolism disorders, ketoacidosis, hyperuricemia, hypercholesterolemia, hypertriglyceridemia, atherosclerosis, and coronary heart disease.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0101060109MULTIPLE PARAMETER BLOOD TEST

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.