Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)

Trade name

Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)

UDI-DI code

06971674860617

Basic UDI-DI

B-06971674860617

Reference / catalog number

R1:60mL×1 R2:20mL×1(703)

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

For the in vitro quantitative determination of low-density lipoprotein cholesterol (LDL-C) content in human serum or plasma. Low-density lipoprotein cholesterol is used for the auxiliary diagnosis of coronary heart disease and atherosclerosis. The lipid deposited in atherosclerotic (AS) plaques is mainly low-density lipoprotein (LDL). Among various types of lipids, low-density lipoprotein (LDL) is regarded as the main pathogenic factor, while high-density lipoprotein (HDL) may play a protective role. Serum total cholesterol (TC) roughly reflects the level of low-density lipoprotein cholesterol, but it is also affected by the level of high-density lipoprotein cholesterol. Therefore, in the identification of lipid-related risk factors for atherosclerosis (AS), when cholesterol levels are high, the determination of low-density lipoprotein cholesterol holds important clinical significance. This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results.The main methods used for low-density lipoprotein cholesterol detection in clinical practice include direct measurement methods, direct method-surfactant clearance methods, and selective inhibition direct methods.

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.

• W01010222NON ESTERIFIED FATTY ACIDS

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