ONE STEP H. pylori Ag Test

Dénomination commerciale

ONE STEP H. pylori Ag Test

06936155803552

B-06936155803552

Numéro de référence/catalogue

ITP10003-TC20

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

ONE STEP H. PYLORI Ag Test is a rapid, serological, immunochromatographic assay for the detection of Helicobacter pylori antigen (Hp) in human feces sample. The test is used to obtain a visual, qualitative result. 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. Helicobacter pylori is a spiral-shaped bacterium associated with gastric and duodenal diseases, including gastritis, gastric ulcer and duodenal ulcer, and H. pylori antigen in feces can be detected using immunochromatographic techniques. The assay is based on a one-step chromatographic immunoassay principle. When the feces sample is applied to the sample pad, H. pylori antigen in the sample reacts with anti-HP conjugates and migrates along the membrane by capillary action. If H. pylori antigen is present, it is captured in the test region to form 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.

• W0105010401H. PYLORI ANTIGEN DETECTION

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

• CW011

  For professional in vitro diagnostic use only. Avoid cross-contamination of feces samples by changing to a new specimen pipette for each sample. Follow the instructions for use carefully. All positive or questionable results should be evaluated together with clinical diagnosis and laboratory findings.
• CW010

  Package insert instructions should be carefully read before testing.
• CW008

  All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. The test device should be discarded in a proper biohazard container after testing.
• CW009

  The test is for single use. Do not re-use