Eu Ivdr
Eu Ivd Class A
On The Market
🇫🇮 Finland
mariPOC® Extraction solution A
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06430080370351
- Basic UDI-DI Code
- 643008037B03AXL
- Reference
- B03A
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- ArcDia International Oy Ltd
Additional Description
The mariPOC® Extraction solutions A and B are to be used in combination with each other in volumetric one-to-one portion. The intended use of the combination of the Extraction solution A and B is to extract the Lancefield's carbohydrate antigen of Group A streptococcus (StrpA reagent). The extraction solutions are used for sample pretreatment in Pharyn and Quick StrepA test reagent configurations.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900201 | BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC |
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