1114M

Organization name

ArcDia International Oy Ltd

SRN

FI-MF-000007553

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  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

06430080370009

Basic UDI-DI

6430080371114MJ9

Reference / catalog number

1114M

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The intended purpose of the test configuration package (test plate) is to provide a container for test reagents and test reactions. Test reagents can be packed in the mariPOC® test plate in different configurations, single or multianalyte. The intended use of the test reagent configuration is to enable the use of test reagents for single or multianalyte analysis from the test configuration package. 1114M mariPOC® Respi test plate includes mariPOC® IVD test reagent devices : 1R01, 1R05, 1R06, 1R07, 1R08, 1R09, 1R10, 1R11, 1R12

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01050799MULTIPLE VIRUSES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification