Neonatal 17-OH-Progesterone FEIA

Nom de l'organisation

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Statut du fabricant

Actif

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• CW159

  Avoid breathing dust/fume/gas/mist/vapours/spray
• CW165

  Contaminated work clothing should not be allowed out of the workplace
• CW166

  Avoid release to the environment
• CW167

  Wear protective gloves/ protective clothing/ eye protection/ face protection
• CW416

  If in eyes: rinse cautiously with water for several minutes, remove contact lenses, if present and easy to do, continue rinsing
• CW158

  Do not breathe dust/fume/gas/mist/vapours/spray
• CW444

  If on skin (or hair): remove/ take off immediately all contaminated clothing, rinse skin with water/ shower
• 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
• CW081

  Causes severe skin burns and eye damage
• CW083

  May cause an allergic skin reaction

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

Commercialisé en Finlande ; dates par pays non publiées.

Dénomination commerciale

Neonatal 17-OH-Progesterone FEIA

Code d'UDI-DI

06438172205031

Basic UDI-DI

B-06438172205031

Numéro de référence/catalogue

6199871

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

Labsystems Diagnostics Neonatal 17-OH-Progesterone FEIA test is a simple competition fluorometric enzyme immunoassay enabling the quantification of 17-hydroxyprogestrone steroid present in blood samples dried on filter paper.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W010205010717 OH PROGESTERONE

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel