Severe acute respiratory syndrome-associated coronavirus IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
23-10-2020

Saadav alates:

PerkinElmer

Klass:

Class 3

Valmistatud:

Wallac Oy Mustionkatu 6, Turku, FI-20750 Finland

Terapeutiline ala:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Näidustused:

The assays are intended for the qualitative detection of SARS-CoV-2 nucleic acids or antibodies as an aid in diagnosing patients suspected of COVID-19 or with an adaptive immune response to SARS-CoV2.

Volitamisolek:

A

Loa andmise kuupäev:

2020-09-01