1194M

Organization name

ArcDia International Oy Ltd

SRN

FI-MF-000007553

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW007

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

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 1 country total.

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

Trade name

not provided

UDI-DI code

D-1194MHH

Basic UDI-DI

B-1194MHH

Reference / catalog number

1194M

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

mariPOC RTI combi+ test plate includes 22 Respi and 22 Pharyn tests for antigen detection of acute respiratory tract infection pathogens. Dried reagents in the test plate recognize the following pathogens: influenza A and B virus, respiratory syncytial virus, adenovirus, human metapneumovirus, human coronavirus OC43, coronavirus SARS-CoV-2, parainfluenza viruses 1-3, S.pneumoniae and S.pyogenes. Product is part of a closed multianalyte mariPOC test system. Assay technique is based on two-photon excitation of fluorescence. For laboratory use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105070599MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER

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• Expiration date
• Manufacturing date
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