Acmex

Dénomination commerciale

Acmex

06976232252170

B-06976232252170

Numéro de référence/catalogue

CA03-112-322P15

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

COVID-19/FLU A+B/RSV/ADV/RHV Combo Rapid Test is a rapid and convenient immunochromatographic assay for the qualitative detection of Covid-19/Influenza A+B/RSV/Adenovirus/rhino.

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

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

• Voir mode d’emploi/manuel d’utilisation

  ·For in vitro diagnostic use only. ·The test is designed only for the detecfon of nasopharyngeal swab and nasal swab specimens.· This testis only for the detection ofproteins from SARS-CoV-2,Influenza A/B,RSVand AV,andRHV,not for any other viruses or pathogens. ·Do not reuse. ·Do not use if the pouch seal orits packaging is compromised. ·Do not use after the expirafion date shown on the pouch. ·Do not mix and interchange different specimens. ·The swabs in the kis are specifcally for use with the COVID-19&Influenza&RSV&AV&RHV Test. Do not use other swabs ·If the test is stbred refngerated,ensure that the test uris are brought to room temper ature(15- 30℃)at least 30 mins before performing testing. ·Perform the test within 1 hour after the reagent or the pouch of test device is opened. ·In order to obtain accurate results,the test must follow this package insert. ·Wear personal protective equipment such as laboratory coats,disposable gloves and eye protection when running each test and handling patient specimens. ·Wash hands thoroughly after firishing the tests ·Do noteat,drink,or smoke in the area where the specimens or kits are being handled. ·Clean up spils thoroughly with appropriate disinfectants. ·Handle allspecimens as if they contain infectious agents.Obserwe established precautions against microbiological hazards throughout testing procedures. ·Dispose of all specimens and used devices in a proper biohazard container.The handling and disposal of the hazardous materials shoukd folow local,nafional,or regionalregulafions. ·Keep out of children's reach. ·f the extraction buffer contacs the skin or eye,flush with copious amounts of water.