32 tests/kit

Dénomination commerciale

non renseigné

06972221450695

B-06972221450695

Numéro de référence/catalogue

32 tests/kit

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

he kit is used for in vitro qualitative detection of suspected cases of novel coronavirus pneumonia, cluster cases, and other throat swabs and sputum samples for diagnosis or differential diagnosis of novel coronavirus infection, novel coronavirus (2019-nCoV) ORF1ab and N gene. Definitions of “suspected cases” and “cluster cases” shall be based on documents such as Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia and Protocol on Prevention and Control for Novel Coronavirus Pneumonia. In use, the relevant requirements of Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia and Protocol on Prevention and Control for Novel Coronavirus Pneumonia and other documents shall be complied. To carry out nucleic acid detection of novel coronavirus, the requirements of Guidance for Laboratory Detection Technology of Novel Coronavirus Pneumonia should be met and good job should be done to ensure biological safety. The testing result of this kit is for clinical reference only, and shall not be concerned as the only criterion for clinical diagnosis. It is suggested to conduct comprehensive analysis on disease state combining with patient’s clinical manifestations and testing result of other laboratory.

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.

• W0105041106CORONAVIRUS - NA REAGENTS