ONE STEP CK-MB Test

Trade name

ONE STEP CK-MB Test

06936155803781

B-06936155803781

Reference / catalog number

ITP08004-TC40

GS1

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 Rapid CK-MB Test is an immunochromatography-based one-step in vitro test. It is designed for the qualitative determination of cardiac CK-MB in human whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction. Myoglobin, CK-MB and cardiac Troponin I are released into the bloodstream after cardiac injury, and CK-MB is a cardiac marker used for the assessment of myocardial infarction. The Rapid CK-MB Test is based on a chromatographic immunoassay principle. When the specimen is applied to the sample pad, it moves through the conjugate pad and mobilizes gold anti-CK-MB conjugate. If CK-MB is present, the immune complex is captured by anti-CK-MB coated on the test region, forming a colored test band. The control band indicates that the test is working properly and the result is valid

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.

• W0102160701CREATINE KINASE - MB MASS - RT & POC

5 warnings recorded — scroll inside the panel to see all entries.

• Caution

  For professional in vitro diagnostic use only. The test result should be used in conjunction with other clinical information such as clinical signs/symptoms and other test results, and all diagnostic decisions should not be based on a single test result alone.

• Consult instructions for use

  Read and follow the package insert carefully before use.; Biological risks: Treat all samples as potentially infectious. Wear gloves and protective clothing when handling samples, clean and disinfect spills using a suitable disinfectant, and dispose of biohazardous materials according to standard safety precautions. Sterilize all kit reagents used in the assay before disposal.

• Do not re-use

  Do not re-use the test card or any single-use accessories.

• Do not use if package is damaged

  Do not use the test card if it has become wet or if the foil pouch is damaged.

• Do not use past indicated date

  Do not use kit reagents beyond their expiration dates.