NeoMass AAAC 3.0

Nom de l'organisation

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Statut du fabricant

Actif

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• 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. 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,” 5th Ed. 2009
• CW057

  Highly flammable liquid and vapo
• CW076

  Harmful if swallowed, in contact with skin or if inhaled
• CW075

  Toxic if swallowed, in contact with skin or if inhaled
• CW082

  Causes skin irritation
• CW083

  May cause an allergic skin reaction
• CW085

  Causes serious eye irritation
• CW090

  May cause respiratory irritation
• CW099

  Causes damage to organs
• CW139

  Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking
• CW158

  Do not breath dust/fume/gas/mist/vapours /spray
• CW159

  Avoid breathing dust/ fumes/ gas/ mist/ vapours/ spray
• CW162

  Wash hands thoroughly after handling
• CW164

  Use only outdoors or in a well-ventilated area
• CW165

  Contaminated work clothing should not be allowed out of the workplace

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

NeoMass AAAC 3.0

Code d'UDI-DI

06438172402010

Basic UDI-DI

B-06438172402010

Numéro de référence/catalogue

NeoMass AAAC 3.0

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

This NeoMass AAAC 3.0 kit is for the quantitative measurement of amino acids, free carnitine, acylcarnitines, argininosuccinic acid, succinylacetone, lysophospholipid and nucleoside in blood samples dried on filter paper as a primary test for screening of newborns for inborn errors of metabolism.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01010402MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.

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