- Safe and user friendly
minimal manual operation required:
1.Dispense the serum into the device
2.Place the device in the instrument
3.Press RUN: the instrument is programmed by the device’s bar-code label.
- The Appropriate solution
for the medium size laboratory.
- Convenient system
The single test device contains all the reagents necessary to perform the assay: no hidden costs or waste of reagents. Master curve procedure with 1 point calibrator included in the kit. Packaging: 36 or 12 devices according to the type of test.
- 98/79/EEC “directive relevant to the In Vitro Medical-Diagnostic Devices (IVD)”
- EN 61010-1 (CEI 66-5) “Safety requirements for electrical equipment for measurement, control laboratory use – Part1: General requirements”. The instrument is classified in Class I
- EN 61010-2-101 “Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirementsfor In Vitro Diagnostic (IVD) medical equipment”.
- EN 61326-1 “Electrical Equipment for Measurement, Control, and Laboratory Use – Electromagnetic compatibility requirements-Part 1: General requirements”
- EN 61326-2-6 “Electrical Equipment for Measurement, Control, and Laboratory Use – Electromagnetic compatibility requirements-Part 2-6: In Vitro Diagnostic (IVD) medical equipment”
- 2006/95/EEC “Low Voltage Directive”
- 2004/108/EEC “Electromagnetic Compatibility Directive”
- 2011/65/EU “Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive – RoHS2”