mariPOC® Group A streptococcus test reagent

Primary DI

D-1R02EF

Basic UDI-DI Code

B-1R02EF

Reference

1R02

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

ArcDia International Oy Ltd

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).