ONE STEP Myoglobin Test

Dénomination commerciale

ONE STEP Myoglobin Test

06936155803774

B-06936155803774

Numéro de référence/catalogue

ITP08003-TC40

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Rapid Myoglobin Test is an immunochromatography-based one-step in vitro test. It is designed for qualitative determination of cardiac myoglobin 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 myoglobin is an early cardiac marker released after muscle cell damage. The Rapid Myoglobin 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-Myoglobin conjugate. If myoglobin is present, the immune complex is captured by anti-Myoglobin 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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0102160702MYOGLOBIN - RT & POC

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Ne pas utiliser si l’emballage est endommagé

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

• Ne pas utiliser après la date indiquée

  Do not use kit reagents beyond their expiration dates.

• Avertissement

  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 diagnostic decisions should not be based on a single test result alone. Do not interchange kit reagents from different lots.

• Consulter la notice d’utilisation

  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, dispose of biohazardous materials according to standard safety precautions, and sterilize all kit reagents used in the assay before disposal.

• Ne pas réutiliser

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