017

Dénomination commerciale

non renseigné

06976043630174

B-06976043630174

Numéro de référence/catalogue

017

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

This product is used for the quantitative determination of anti-dsDNA antibody in human serum, plasma and whole blood in vitro. In clinical practice,it is mainly used for the auxiliary diagnosis of systemic lupus erythematosus and to monitor the changes in the clinical course (especially lupus nephritis).

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.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

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

• CW011

  1. This product is for in vitro diagnostic use only. The procedure must be performed strictly according to these instructions for use. 2. This test is a molecular diagnostic procedure. The testing laboratory should meet the requirements of the National Center for Clinical Laboratories for clinical laboratories. 3. After the experiment, chips containing PCR amplification products should be sealed in a self-sealing bag and disposed of in a designated container.
• CW008

  Microbial and Infection Status: The product does not contain any infectious substances and will not infect humans or other animals. Specimens to be tested should be considered potentially infectious. Their handling should be performed in a microbiology or biomedical laboratory equipped with biohazard safety signs and appropriate biosafety containment conditions to protect operators from potential infectious agents