Neonatal Toxoplasma gondii IgM FEIA

Nom de l'organisation

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Statut du fabricant

Actif

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

• CW008

  All human materials used in the preparation of the calibrators/controls in the kit have been tested for the presence of the antibodies to HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) as well as Hepatitis B surface antigen (HBsAg) and found to be non-reactive. Because no test method can offer complete assurance that HIV, hepatitis B virus, HCV, or other infectious agents are absent, these calibrators and controls as well as samples should be handled at the Biosafety level 2 as recommended for any potentially infectious human serum or blood sample in the Centers for Disease Control and prevention/National Institutes for Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 5th Ed. 2009
• CW999

  Relevant R-phrases: 34 Causes burns 36/38 Irritating to eyes, respiratory system and skin. 43 May cause sensitization by skin contact. Relevant S-phrases: 24/25 Avoid contact with skin and eyes 37 Wear suitable protective clothes and gloves

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

Neonatal Toxoplasma gondii IgM FEIA

Code d'UDI-DI

06438172116016

Basic UDI-DI

B-06438172116016

Numéro de référence/catalogue

6199802

Entité d'attribution

GS1

Catégorie de risque

IVDD — Annexe II Liste B

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

This Neonatal Toxoplasma gondii IgM FEIA kit is intended for the determination of IgM-class antibodies to Toxoplasma gondii in blood samples dried on filter paper. The test is intended as a primary method for screening of newborns for congenital toxoplasmosis (CT). Because IgM-class antibodies due to their high molecular weight do not cross placenta, determination of specific antibodies in newborn samples taken shortly after birth indicates exposure of the fetus intra utero to Toxoplasma gondii. Cases showing elevated levels of specific antibodies should be further investigated.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105050103TOXOPLASMA ANTIBODY IGM

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