Copper (Cu) Test Kit (Colorimetric)

Trade name

Copper (Cu) Test Kit (Colorimetric)

UDI-DI code

06971674865919

Basic UDI-DI

B-06971674865919

Reference / catalog number

R1:48mL×2 R2:16mL×2（798）

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 detection of copper (Cu) content in human serum. Copper is a trace element widely distributed in the human body. Copper in serum mainly exists in the forms of ceruloplasmin-copper and albumin-Cu²⁺. As an important component of copper-containing enzymes, copper plays a crucial role in cellular, respiratory, neurological, and endocrine functions. The determination of serum copper concentration can be used to diagnose Wilson's disease, Menkes syndrome, bone diseases, and hepatobiliary system diseases. 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 copper detection in clinical practice include the colorimetric method, complexation method, and PAESA chromogenic reagent method.

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.

• W01010206COPPER

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