ONE STEP Myoglobin/CK-MB-cTnI Combo TEST

Trade name

ONE STEP Myoglobin/CK-MB-cTnI Combo TEST

06936155803798

B-06936155803798

Reference / catalog number

ITP08101-TC20

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 Myoglobin/CK-MB/Troponin I Test is an immunochromatography-based rapid in vitro test. It is designed for qualitative determination of cardiac Myoglobin/CK-MB/Troponin I 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 these cardiac markers are used for the assessment of myocardial infarction. The Rapid Myoglobin/CK-MB/Troponin I Test is based on a chromatographic immunoassay principle. When the specimen is applied to the sample pad, it migrates through the conjugate pad and reacts with specific capture reagents on the membrane, generating colored lines in the corresponding test regions when the target analytes are present. The procedural control line indicates that the appropriate volume of sample has been added and membrane wicking has occurred.

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.

• W0102160706MULTIPLE CARDIAC MARKERS - RT & POC

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

• CW011

  For professional in vitro diagnostic use only. This test provides qualitative results only and cannot determine the concentration of Myoglobin, CK-MB or Troponin I. The test result should be used in conjunction with clinical signs/symptoms and other test results, and diagnostic decisions should not be based on a single test result alone. Do not interchange kit reagents from different lots.
• CW010

  Read and follow the package insert carefully before use.
• CW008

  Treat all samples as potentially infectious. Wear gloves and protective clothing when handling samples, clean and disinfect spills using a suitable disinfectant, dispose of biohazardous materials according to standard safety precautions, and 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.
• CW007

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