Creatine Kinase MB

Organization name

Cypress Diagnostics

SRN

BE-MF-000000033

Manufacturer status

Active

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• CW010

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Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

Creatine Kinase MB

UDI-DI code

05404035101537

Basic UDI-DI

B-05404035101537

Reference / catalog number

HBEL05

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

The Cypress Diagnostics kit Creatine Kinase MB is an in vitro diagnostic medical device intended to be used for the quantitative measurement of creatine kinase MB in human serum free of hemolysis, or heparin plasma. The device is not automated. The measurement of creatine kinase MB is intended to be used to aid to identify acute infarct of myocardium disease or more rarely, skeletal muscle damage, in patient risk population. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment. For in vitro diagnostic use only. For professional use only.

Additional information URL

https://www.diagnostics.be/

Clinical sizes

No clinical sizes registered for this device.

• W01010114CREATINE KINASE - MB ACTIVITY (CC)

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