ONE STEP Pregnancy (hCG) Test

Dénomination commerciale

ONE STEP Pregnancy (hCG) Test

06936155803576

B-06936155803576

Numéro de référence/catalogue

ITP04002-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 ONE STEP Pregnancy (hCG) Test is a rapid, qualitative immunochromatographic assay for the detection of human chorionic gonadotropin (hCG) in serum, plasma or urine, indicating early pregnancy. The test provides only preliminary analysis results but not critical diagnostic criteria, and the obtained results should be analyzed in connection with other clinical information and alternative tests to make the final decision. The test is intended for healthcare professional use. Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in urine and serum soon after conception, and its concentration rises rapidly during early pregnancy. The test is a sandwich immunoassay. When an adequate specimen is applied to the sample pad, hCG in the specimen reacts with anti-hCG monoclonal antibody-colloidal gold conjugate and migrates along the membrane. If hCG is present at or above the detection level, the immune complex is captured in the test region to form a visible colored band, while the control band indicates that the reagents and device are functioning 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.

• W0102160302HCG - RT & POC

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

• CW011

  For professional in vitro diagnostic use only. The test provides preliminary qualitative results for hCG detection and should be interpreted together with clinical information. Do not interchange kit components between different lots.
• CW010

  Read the package insert carefully before use and strictly follow the instructions.; Biological risks: Handle all specimens as potentially infectious and follow standard safety precautions. Dispose of used testing materials according to applicable biohazard procedures.
• CW009

  Do not reuse test devices or disposable accessories.
• CW007

  Do not use the test device if the foil pouch is damaged or opened before testing.
• CW032