Validity of a SKUP report

SKUP does not set a period of validity on the evaluation results, nor does SKUP specify which product changes can be made without losing the validity of the initial evaluation report.

The time SKUP evaluated a product is stated in the report. The evaluated instruments should be in standard version and representative for the instruments on the market. If possible three lots of reagents/test strips/cassettes are included in the evaluation. The SKUP evaluation is applicable solely for the instruments and the reagent/test strip/cassettes lots used in the evaluation and cannot guarantee that other instruments or lot numbers of reagent/test strip/cassettes give identical results.

It is solely the manufacturer of the instrument and the reagents/test strips/cassettes that can assure that the performance and other characteristics of a measuring system for sale are equivalent to those evaluated by SKUP. Upon request, SKUP can evaluate product modifications. If the product has been evaluated earlier, SKUP and the manufacturer/supplier will discuss if a full evaluation is needed or if it is more appropriate with a supplement evaluation of the modified properties alone.