Intersystem GmbH is the sales partner for customized newborn screening laboratory cards, which are manufactured by a highly specialized producer.
The blood collection papers for neonatal screening laboratory cards are produced in conformity with the applicable requirements of the standard CLSI NBS01A6 (Clinical & Laboratory Standards Institute, Blood Collection on Filter Paper for Newborn Screening Programs, 6th Edition).
In Europe they are placed in the market as „CE“ certified medical devices for in vitro diagnostic purposes according to IVDR 2017/746.
The laboratory cards for newborn screening offer an individual design for each specific purpose and therefore a wide range of possibilities to meet your individual requirements.
The cards are classified according to GIVD 51 01 (Global In-Vitro-Diagnostic Classification) as a sample collection container (container) for human dry blood and sera. Similar to forms, they are offered as pre-prints. The laboratory cards usually consist of a combination of medical filter paper printed with target circles for sample collection and storage as well as an area made of white plain paper, which is intended for demographic information about the newborn (so-called combination card, see below).