1R02

Organization name

ArcDia International Oy Ltd

SRN

FI-MF-000007553

Manufacturer status

Active

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-1R02EF

Basic UDI-DI

B-1R02EF

Reference / catalog number

1R02

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

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® Group A streptococcus (Streptococcus pyogenes) test reagent is intended to be used for the detection of Streptococcal Lancefield group A antigens when there is a suspicion of pharyngitis or streptococcal dermatitis, such as that of perianal area. The test reagent may be used for individuals with or without symptoms, in serial testing and in monitoring to assess the contagious phase of the infection. 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) oropharyngeal or dermatitis specimen. 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 (Quick StrepA) as positive (+) or negative (−), or semi-quantitatively (Pharyn) as + (very low), ++ (low), or +++ (high) on the graphical user interface of the mariPOC® Software depending on the test reagent configuration.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105011101STREPTOCOCCAL DIRECT ANTIGEN DETECTION

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