2017MC

Organization name

ArcDia International Oy Ltd

SRN

FI-MF-000007553

Manufacturer status

Active

3 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.
• CW008

  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-2017MCQK

Basic UDI-DI

B-2017MCQK

Reference / catalog number

2017MC

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 Gastro control samples is intended for use as known control samples in the mariPOC Gastro test. Package includes a positive control sample dried in a flocked swab and a negative control sample inside bar coded tubes. Positive control sample includes all analytes in the mariPOC gastro test. Product is part of a closed multianalyte mariPOC test system intended to be used for rapid detection of acute gastrointestinal infection pathogens using antigen detection. 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.

• W0201020299LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER

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• Expiration date
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