Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-GMDN440824D
- Basic UDI-DI Code
- B-GMDN440824D
- Reference
- 012016
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- iSTOC Oy
Additional Description
The system consists of a generic software reader in mobile device and a software information system. The software reader which utilizes mobile device camera interprets the result of a lateral flow test (LFT) result based on manufacturer instructions, for example, from infectious disease tests, and the test result is then ultimately confirmed by the user. The image and the test result are transferred to a cloud based software information system. IDA solution converts the diagnostic data into immediate and actionable health information.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020192 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE |
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