Rapid FOB Test

Dénomination commerciale

Rapid FOB Test

06936155804443

B-06936155804443

Numéro de référence/catalogue

ITP13001-DS50

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 FOB Test is a rapid, serological, immunochromatographic assay for the detection of hemoglobin (Hb) in human feces. 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. The detection of fecal occult blood is important for the diagnosis of diseases resulting in gastrointestinal bleeding and for screening colorectal cancers and large adenomas that bleed. The assay is based on a chromatographic immunoassay principle for the qualitative determination of hemoglobin in human feces. When the feces sample is applied to the sample pad, hemoglobin, if present, reacts with gold anti-Hb conjugate and is captured by anti-Hb 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.

• W0102039013FECAL OCCULT BLOOD (IC)

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

• Ne pas réutiliser

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

• Risques biologiques

  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.

• Avertissement

  For professional and in-vitro diagnostic use only. Follow the instructions for use carefully. All positive results must be confirmed by an alternate method. Avoid cross-contamination of feces by changing to a new specimen pipette for each sample.

• Consulter la notice d’utilisation

  Read the package insert carefully before testing.