Rapid Malaria Test (P.f/Pan)

Dénomination commerciale

Rapid Malaria Test (P.f/Pan)

06936155803736

B-06936155803736

Numéro de référence/catalogue

ITP11005-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 Malaria Test (Pf/Pan) is a rapid, qualitative and differential test for the detection of HRP-II (Histidine-rich protein II) specific to Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) pan (P. vivax, P. malariae, P. ovale) specific to Plasmodium species in human blood sample. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision. The test is intended for healthcare professional use. Malaria infection caused by P. falciparum and/or non-P. falciparum Plasmodium species can be rapidly detected through malaria-specific antigens in human whole blood. The test is based on a colloidal gold immunochromatographic principle, in which malaria antigens in the specimen react with gold-conjugated antibodies and are captured by immobilized antibodies on the membrane, forming visible Pf and/or Pan test lines when the corresponding antigen is present. The control line indicates that the test has been performed properly.

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.

• W0105090401PLASMODIUM (MALARIA) - RT & POC

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

• CW011

  For in vitro diagnostic use only. Follow the instructions for use carefully.
• CW010

  Read the instructions for use carefully before use.
• CW008

  Treat all specimens as potentially infectious. Wear gloves and protective clothing when handling specimens and dispose of biohazardous materials according to standard safety precautions.; 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.
• CW032

  Do not use kit reagents beyond their expiration dates.