POCBio Syphilis Antibody Rapid Test

Dénomination commerciale

POCBio Syphilis Antibody Rapid Test

06974912093778

B-06974912093778

Numéro de référence/catalogue

LATB04-C50

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

The POCBio Syphilis Antibody Rapid Test (Whole Blood/Serum/Plasma) is an immunochromatographic assay enhanced by colloidal gold, designed for the qualitative detection of antibodies against Treponema pallidum (anti-TP) in human whole blood (fingerstick or venous), serum, or plasma. This test serves as an aid in diagnosing syphilis infection. It is a non-automated assay that does not require additional instruments. The test is intended for use by healthcare professionals and trained laboratory personnel.

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.

• W0105090105SYPHILIS - RT & POC

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

• CW999

  1. The kit is designed for human whole blood, serum or plasma. Other body fluids or pooled specimens may not give accurate results. 2. A negative result at any time does not preclude the possibility of Treponema pallidum infection. The specimen may contain low levels of anti-TP antibodies that cannot be detected by the POCBio Syphilis Antibody Rapid Test (Whole Blood/Serum/Plasma). If a test result is nonreactive and clinical symptoms persist, additional testing using other clinical methods is recommended. 3. A positive result should be confirmed by a supplemental test. For overall clinical diagnosis, results must be used in conjunction with the patient's clinical symptoms, and clinical history.