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Dénomination commerciale

non renseigné

06956013941929

B-06956013941929

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

In vitro diagnostic test kit for qualitative detection of hemoglobin in stool specimens. Single-use rapid test for professional in vitro diagnostic use in clinical laboratories and medical clinics, results for auxiliary clinical reference only, not for treatment.

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.

• W0102160203FECAL OCCULT BLOOD - RT & POC

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

• 1. This test kit is for IVD (In Vitro Diagnostic) use only. 2. For manual testing, we recommend that the rapid test kit be used within 1 hour after opening and even be used immediately after opening especially under temperature over 40℃ or high humidity. For instrumental testing, we recommend that the rapid test kit be used within 24 hours after opening. 3. Any source of blood will give a positive test result while using this test kit. Blood from another source, like hematuria, bleeding mouth, nose, hemorrhoids or menstrual period may interfere the test results. 4. The interval or very few amount of gastrointestinal hemorrhage may give a negative result. 5. Improper operation, too much or too few sample, or too long time may cause inaccurate results. 6. The test kit is disposable as medical waste. 7. The stored sample shall be brought back to 10℃~30℃ before testing.

  AUTRE