5.237.XXX.88.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

Primary placement in Spain; available across 3 countries total.

Trade name

not provided

UDI-DI code

D-84295775237XEGW

Basic UDI-DI

B-84295775237XEGW

Reference / catalog number

5.237.XXX.88.ZZZ

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Real SARS CoV-2/Flu/RSV test is designed to detect and qualitatively differentiate the following viruses using the RT PCR Real Time method: coronavirus SARS-CoV1/2, Influenza virus (Flu A/B) and respiratory syncytial virus (RSV A/B), in samples from individuals with symptoms of infection in respiratory tracts. This involves using primers and probes that can amplify and detect a region of the E gene, specific to sarcovirus-type coronaviruses (SARS-CoV-1 and SARS-CoV-2), a region of the M gene, specific to Influenza viruses (Flu A/B), and a region of the N gene, specific to the respiratory syncytial viruses (RSV A/B). Real SARS CoV-2/Flu/RSV has been validated for use with respiratory samples, such as nasopharyngeal swabs, nasal swabs, oropharyngeal swabs, saliva and nasopharyngeal aspirates, as well as with nucleic acids extracted from those samples. The product is intended for specialised users as a means of support when diagnosing individuals suspected to have a viral respiratory infection. The clinical symptoms caused by the SARS-CoV-2, Influenza, and RSV viruses can be similar. The product can be used for any indication involved with virus detection: initial diagnosis, infection monitoring, and contact control. Take also under consideration other parameters such as symptoms or clinical history when giving the final diagnosis.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105070304INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS

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