Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06430030990837
- Basic UDI-DI Code
- 643003099ACTIM191015K
- Reference
- 19101AC
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Actim Oy
Additional Description
The Actim® 1ngeni is an automated rapid in vitro diagnostic instrument. The instrument has been designed to provide quantitative and/or qualitative results of immunochromatographic colorimetric tests measuring various analytes from patient samples to aid in diagnosis and treatment monitoring. The instrument is intended to be used by healthcare professional in clinical laboratories and near-patient testing (NPT) settings. The instrument is intended to be used with the Actim 1ngeni test kits. Target population is defined by the associated assays. Specimen type is based on the associated assays.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0299 | IVD INSTRUMENTS - OTHER |
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