IDTM SARS-CoV-2/Influenza TriplexIDTM SARS-CoV-2/Influenza Triplex

Organization name

ID SOLUTIONS

SRN

FR-MF-000024876

Manufacturer status

Active

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• CW043

  EUDAMED did not publish a description for this code.
• CW044

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW106

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Trade name

IDTM SARS-CoV-2/Influenza TriplexIDTM SARS-CoV-2/Influenza Triplex

UDI-DI code

03760367184610

Basic UDI-DI

B-03760367184610

Reference / catalog number

IDRESPI-P1-500 (FR) - Boîtes

Issuing entity

GS1

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

test de diagnostic in vitro basé sur la technologie de la RT-PCR en temps réel (ou RT-qPCR) pour la détection qualitative de l'ARN viral du coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2) et des ARN viraux des virus de la grippe A et B (Influenza A/B) après extraction à partir d’échantillons de patients (cf ci-dessous le détail). Ce test s’inscrit dans le besoin de diagnostiquer et différencier les grippes saisonnières d’une infection par le SARS-CoV-2.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105041106CORONAVIRUS - NA REAGENTS

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• Expiration date
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• Serial number
• Software identification