NeoMass AAAC Plus dried blood spot (DBS) controls

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.

• 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. As no test method can offer complete assurance that HIV, hepatitis B virus, HCV, or other infectious agents are absent, these calibrators, controls and 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 wastes 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. Avoid contact with skin and eyes when handling extraction and elution solutions.

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

NeoMass AAAC Plus dried blood spot (DBS) controls

Code d'UDI-DI

06438172403024

Basic UDI-DI

B-06438172403024

Numéro de référence/catalogue

710011003

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

NeoMass AAAC Plus DBS controls is a component of Neomass AAAC plus kit for newborn screening

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0101050101ASSAYED MULTICOMPONENT CONTROLS (CC)

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