Biocard Helicobacter pylori IgG

Nom de l'organisation

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW011

  If the Instructions for use are not followed in detail, outcome of the test may be false.  Poor observation of the general laboratory precautions in conjunction with the use of the Biocard tests can expose persons to microbial hazards as well as false and misleading results.  Do not use the test after the expiry date.  Do not use the test if the aluminum pouch is damaged. Do not use broken accessories.  All the test components are intended for this test only. Do not reuse tests or accessories.  The sample diluent and positive control contain 0.09 % sodium azide. Avoid contact with the skin. Do not swallow!  A diagnosis should not be made solely according to the Biocard™ Helicobacter pylori IgG –test result. The result should be used in conjunction with additional diagnostic information available for the physician.  Do not use tests from a lot not showing proper performance when tested with controls.  Positive control has been made of pooled, commercial human serums. Although the positive control does not contain infectious agents, it should be handled as a potential biohazard.  General laboratory procedures and precautions shall be followed in the handling and disposal of samples and used materials

Marché principal en Finlande ; disponible dans 1 pays au total.

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

Biocard Helicobacter pylori IgG

Code d'UDI-DI

06416842818019

Basic UDI-DI

B-06416842818019

Numéro de référence/catalogue

3-018-110

Entité d'attribution

GS1

Catégorie de risque

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

Biocard™ Helicobacter pylori IgG is an immunochromatographic test for screening of Helicobacter pylori antibodies in whole blood, serum or plasma samples

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105010402H. PYLORI ANTIBODY ASSAYS

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel