The solution pack for the Vi-CELL MetaFLEX enables ease-of-use with on-screen instructions and simple step-by-step guidance. All necessary fluids are contained within this replaceable solution pack. The solution pack also contains the solutions required to perform internal quality control and calibrations, as well as a container for waste.
It has an in-use lifetime of 30 days (or until the solution pack is empty. Its shelf life is 4 months and should be stored at a temperature between 2-25 °C / 35 -77 °F
All of the measurements performed by the MetaFLEX are conducted within the sensor cassette, and all necessary fluids are contained within a replaceable solution pack. The solution pack also contains the solutions required to perform internal quality control and calibrations, as well as a container for waste.
|Industry Standards||21 CFR Part 11|
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.