Basic Information
- Primary DI
- 05060969430046
- Basic UDI-DI Code
- 506096943BB20H2S
- Reference
- BB20-H
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Bee Robotics
Additional Description
The B20 is a semi-automated standalone Class A in vitro diagnostic instrument for use with reverse line blot strip assays which use blood specimens. The B20 develops up to 20 membrane strips through the assay process which typically involves addition, removal and incubation of various reagents and wash solutions. Once the assay process is finished, the developed strips can be removed and either analyzed by eye or used with an automated scan-ner such as the AutoCam 48 instrument. Interpretation of the developed strips may then be performed using third-party software. The B20 is suitable for use with samples from all groups of people in the strip development process. It is to be used by trained personnel with samples and reagents (diagnostic kit) that are appropriate for the B20. The product is intended for professional use in a Laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020180 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).