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Organization name
UDI-DI code
Reference / catalog number

2R03 — IVDD — General IVDD by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on May 23, 2022

2R03

B-2R03EQ

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ArcDia International Oy Ltd
UDI-DI code: D-2R03EQ
Reference / catalog number: 2R03

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Manufacturer information

Organization name: ArcDia International Oy Ltd
SRN: FI-MF-000007553
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-2R03EQ
Basic UDI-DI: B-2R03EQ
Reference / catalog number: 2R03
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The test reagent devices consist of polystyrene microparticles as a solid phase carrier coated with affinity binders, such as monoclonal or polyclonal antibodies. specific for the analyte (antigen), and fluorescent affinity binder, such as monoclonal or polyclonal antibody, conjugates as a tracer. The immunoassay active components are dried with protective sugars and buffer components inside individual reaction chambers on test configuration packages. The mariPOC® Clostridium difficile GDH test reagent is intended to be used for the detection of glutamate dehydrogenase of Clostridium difficile from stool specimens when there is a suspicion of acute gastroenteritis and/or antibiotic associated diarrhoea (i.e. C. difficile infection, CDI). The function of the device is for screening and/or aid to diagnosis in order to provide specific information on the physiological state by providing limited information on the microbiological content of the specimen. Intended specimen type is native (unprocessed) human feces. The use of the device is automated and the device is stored in dry format inside mariPOC® test plate reaction wells. The results are reported qualitatively as positive (+) or negative (−) on the graphical user interface of the mariPOC® Software.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011801C.DIFFICILE GDH DETECTION

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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