Neonatal Phenylalanine

Dénomination commerciale

Neonatal Phenylalanine

06438172085015

B-06438172085015

Numéro de référence/catalogue

6199896

GS1

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

The kit is designed for the quantitative in vitro determination of phenylalanine concentration in blood specimens dried on filter paper intended for newborn screening for phenylketonuria (PKU).

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.

• W01010236PHENYLKETONURIA

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• Contient une matière biologique d’origine humaine

  Each donor unit used in the preparation of the kit calibrators and controls has been tested for the presence of the antibodies to HIV (human immunodeficiency virus) and HCV as well as for hepatitis B markers and found to be negative. Because no test method can offer complete assurance that HIV, HCV, hepatitis B virus, or other infectious agents are absent, these calibrators, controls as well as specimens should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health manual “Biosafety in Microbiological and Biomedical Laboratories”, 2009. In addition, handle and dispose of the Microstrips® as well as all material coming into contact with them or with the specimens, calibrators and controls as if capable of transmitting infection. Discard solutions into a waste drainage network and flush with large volumes of water.

• Risques biologiques

  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 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.