NeoMass CAH Multilevel Calibrators, Dried Blood Spot Calibrators Level 0-7

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

  POTENTIAL BIOHAZARDOUS MATERIAL: 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, HBV, 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. 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. Wear disposable gloves while handling samples and kit reagents. Afterwards wash hands carefully. Never pipette by mouth. Do not interchange reagents or vial caps. Once the assay has been started, all subsequent steps should be performed without interruption. Strict adherence to the protocol is advised to obtain reliable results. Any modification or change made to the kit or the assay procedures are under the responsibility of the user.

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

NeoMass CAH Multilevel Calibrators, Dried Blood Spot Calibrators Level 0-7

Code d'UDI-DI

06438172401020

Basic UDI-DI

B-06438172401020

Numéro de référence/catalogue

3467700

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

NeoMass CAH Multilevel Calibrators Dried Blood Spot Calibrators Level 0-7 used with the Neomass CAH kit (Cat#7150022) for performing the Assay.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102152202HORMONE STANDARDS AND CALIBRATORS

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