EUDAMED a mis à jour ce dispositif le 17 avr. 2026

SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)

B-06971225931667

Sur le marchéIVDD — Général

Législation applicable: IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]
Nom de l'organisation: Goldsite Diagnostics Inc.
: 06971225931667
Numéro de référence/catalogue: CG123005

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SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing) est un dispositif de diagnostic in vitro historique relevant de la directive IVDD, enregistré dans EUDAMED. Il est classé en IVDD — Général. Fabriqué par Goldsite Diagnostics Inc.. Commercialisé sur le marché européen en Italie. Découvrez les certificats, le statut réglementaire et la fiche EUDAMED sur MD Atlas.

Identification du dispositif

Dénomination commerciale: SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)
: 06971225931667
: B-06971225931667
Numéro de référence/catalogue: CG123005
: GS1

Classification

: IVDD — Général
Législation applicable: IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]
Statut: Sur le marché

Détails sur le dispositif

Quantité: 1
Description complémentaire du produit: This SARS-CoV-2 Antigen Kit (Colloidal Gold) is a single use, in vitro visually read rapid immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid (N) antigen in human nasal swab specimens. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but correlation with patient history and other diagnostic information is necessary to determine the infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. The SARS-CoV-2 Antigen Kit (Colloidal Gold) is intended to be used manually by lay users (self-testing) in a private setting to aid in the rapid diagnosis of SARS-CoV-2 infections. Children (at least 2 years old) younger than 15 years old should be tested by an adult. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
URL des informations complémentaires: Aucune URL d'informations complémentaires renseignée par le fabricant.
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SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)

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