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Dénomination commerciale

non renseigné

06956013925073

B-06956013925073

Numéro de référence/catalogue

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GS1

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

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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.

• W01040699CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 1. This product is an in-vitro diagnostic product for the disposable repeated sampling, and shall be used within the valid period. 2. Please store the QC products under the conditions provided by the manufacturer to avoid the deterioration. 3. Since there is a difference between the upper and lower test limits of the reagent strips of different manufacturers, in order to achieve the better indoor quality control effect, the laboratory can slightly adjust the added amount to make the concentration is closer to the upper and lower test limits of the used reagents. Meanwhile, the quality control rules and the judgment basis for the loss of control shall be adjusted according to the specific operation of the laboratory. 4. It is not allowed to use the QC products of different batches simultaneously, and before the use of the QC products of the new batch, the comparison test of the QC products of the previous batches should be conducted. 5. The product is only for the in-vitro diagnosis. Don't suck with the mouth. During the use, the laboratory's routine preventive measures to operate the reagents should be taken. 6. The signals for the loss of control are affected by many factors, including the QC material, reagent, instrument, operation and quality control rules. Once the signal occurs, the laboratory shall carefully analyze the cause, find the root causes, and do not stick to the recommended stylized steps. Instead, it should conduct the investigation work based on the source of errors and the actual implementation of the work of the current batch. 7. The product contains the preservatives. The uptake or contact with the skin and mucous membrane shall be avoided. In case of the contact with the skin, flush the affected part with plenty of water. In case of contact with eyes or uptake, take the medical measures immediately. 8. After the use of the product, the wastes produced shall be disposed properly according to relevant national regulations.

  AUTRE