mariPOC® Pneumococcus respiratory test reagent

Primary DI

D-1R11EG

Basic UDI-DI Code

B-1R11EG

Reference

1R11

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® Pneumococcus respiratory test reagent is intended to be used for the detection of Streptococcus pneumoniae antigens when there is a suspicion of acute upper or lower respiratory tract infection. Pneumococcus is not indicated in small children due to the high frequency of asymptomatic carriers. 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. The value of negative S. pneumoniae test result is in ruling out S. pneumoniae aetiology (high negative predictive value). Intended specimen type is native (unprocessed) nasopharyngeal swab or aspirate. 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 semi-quantitatively as + (very low), ++ (low), +++ (medium), or ++++ (high) on the graphical user interface of the mariPOC® Software.

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