R401T005B0C2

Dénomination commerciale

non renseigné

06970895476225

B-06970895476225

Numéro de référence/catalogue

R401T005B0C2

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

This kit is intended for qualitative detection of ORF genes of 2019-Novel Coronavirus (2019-nCoV, SARS-COV-2) and mutants including B.1.617.2(δ) and B.1.617.1(κ) in the specimens including nasopharyngeal swab, oropharyngeal swabs, bronchoalveolar lavage fluid, saliva, sputum and fecal. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. During the pandemic, various mutants appeared and showed different characters. This kit is only for emergency use during the pandemic of 2019-nCoV. The test is manually operated. Experimental personnel who perform this test should have received professional training in gene amplification or molecular biology diagnostics and be qualified for relevant experimental operations. There should be reasonable biosecurity precautions and protective procedures in the laboratories. The test should only be performed in laboratories that follow safety practices according to the applicable Biosafety Regulations in Microbiological and Biomedical Laboratories. The results of this kit are only for aiding to diagnosis and shall not be used as the sole basis for diagnosis or exclusion.

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