Neonatal Biotinidase

Nom de l'organisation

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Statut du fabricant

Actif

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• CW263

  BIOLOGICAL RISKS. CONTAINS HUMAN BLOOD OR PLASMA DERIVATIVES. 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,” 6th Ed. 2020. Discard all materials and samples as if capable of transmitting infection. The preferred method of disposal is autoclaving for a minimum of one hour at +121°C. Liquid waste not containing acid and neutralized waste may be mixed with sodium hypochlorite in volumes such that the final mixture contains 50-500 mg/l free available chlorine. Allow 30 minutes for decontamination to be completed. Spills should be wiped off thoroughly using either an iodophor disinfectant or sodium hypochlorite solution. Materials used to wipe off spills should be added to biohazardous waste matter for proper disposal. Reusable glassware must be disinfected, washed out and rinsed free of detergents.

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

Neonatal Biotinidase

Code d'UDI-DI

06438172218017

Basic UDI-DI

B-06438172218017

Numéro de référence/catalogue

6199821

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

Neonatal Biotinidase kit is for enzymatic determination of human biotinidase enzyme activity from blood samples dried on filter paper. Intended for newborn screening of biotinidase deficiency. For professional laboratory use only. Both manual use and NS2400 automate use.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01010199ENZYMES - OTHER

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