LYHER

Dénomination commerciale

LYHER

06972412614721

0697241261IRS-572BQ

Numéro de référence/catalogue

IRS-572

GS1

IVDR Classe B

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

"The Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV)is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A virus, influenza B virus, respiratory syncytial virus (RSV) Adenovirus Mycoplasma pneumoniae or human metapneumovirus in nasopharyngeal swab, oropharyngeal swab or nasal swab specimens. The device detects any combination of the above viruses. Antigen tests are generally used for acute phase of infection, this test detects the antigen in specimen from individuals who are suspected of relative virus infection within 7 days of symptom onset. This test only provides an aid to diagnosis of novel coronavirus (SARS-CoV-2), influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection and human metapneumovirus infection. The infection status should be determined in combination with other diagnostic information such as PCR tests or medical image science, exposures and medical history. Positive results only indicate the presence of viral antigens in specimens and cannot determine the infection status. Positive results can be used for patient diversion and rapid management decisions. Negative results cannot rule out the SARS-CoV-2, influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection or human metapneumovirus infection, and should not be used as sole basis for treatment or patient management decisions. Both positive and negative results for suspected cases should be determined by a further molecular assay (e.g., PCR test)."

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.

• W0105090699OTHER MULTIPLE PATHOGENS - RT & POC