MQHM Z

Nom de l'organisation

Milenia Biotec GmbH

SRN

DE-MF-000028733

Statut du fabricant

Actif

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

• CW266

  The reagents provided in these kits contain materials of human and/or animal origin. Whenever human blood product is required for the preparation of these reagents, approved methods are used to test the blood for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.
• CW010

  Read these instructions for use carefully before performing the test. Follow them step by step
• CW267

  The reagents provided in these kits contain materials of human and/or animal origin. Whenever human blood product is required for the preparation of these reagents, approved methods are used to test the blood for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.
• CW007

  Do not use Test Unit if foil pouch is damaged.
• CW132

  Material Safety Data Sheets are available on request (look as well www.milenia-biotec.de).

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260177043002

Basic UDI-DI

B-04260177043002

Numéro de référence/catalogue

MQHM Z

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

The Milenia QuickLine HAMA is an in-vitro diagnostic lateral flow immunoassay for the qualitative detection of human anti-mouse IgG antibodies in human serum. The test is used in adult patients with suspected human anti-mouse IgG antibodies due to previous exposure to mouse antibodies (IgG). The analysis is performed indoors by laboratory personnel only.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102010113HUMAN ANTI-MOUSE ANTIBODY

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