Innovative devices especially designed for cell block preparation from different types of cytological specimens, allowing quality and standardization of the set-up process. 1 pack of 20 pcs

The purchase of the Products, including in vitro diagnostic devices (IVD), is reserved exclusively to authorized professional operators active in the healthcare and diagnostic laboratory sectors, including physicians, clinical analysis laboratories, pathology, cytology and histology laboratories, as well as other authorized facilities and professionals, holding a VAT number and classified under an ATECO/NACE code consistent with the relevant activity carried out, in particular within the field of clinical/diagnostic laboratory activities. The use of the Products is permitted exclusively for the “intended use” indicated in the “Instructions for Use” (IFU) relating to the relevant Product, always available in their updated version on the website www.diapath.com.

Intended use
Single-use, non-sterile in vitro diagnostic device for clinical use, for the collection, uptake and preparation of cell block material in vitro, previously obtained in accordance with the method of reference for the type of histological sample, which can then be used in the various processing stages envisaged in an anatomical pathology laboratory, including molecular biology and immunohistochemistry techniques. The device is compatible with commercially available cytology fixatives.
CytoPath®- Disc 12mm is packaged, ready for use.
The IVD CPD12 device must only be used by experienced and qualified personnel, by means of manual operation, free of toxic reagents. The device is a circular disc of polymeric material used in conjunction with consumables, such as falcon, eppendorf, pipettes, and instruments, such as centrifuge, processor, embedding station, microtome, stainer.
The CytoPath®- Disc 12mm IVD device allows the uptake of the cytological pellet, once it has been inserted into the falcon, from which the supernatant has already been separated and removed, in accordance with the laboratory’s procedures, making it available for subsequent anatomical pathology processing and enabling the preparation of a cell block.
The device does not come into contact with the patient as it is a diagnostic aid; it is used in the sample preparation stage for research or diagnostic purposes.
The device does not provide specific results as it is involved in the treatment process in order to prepare the sample for the next step; therefore, the device is an aid to diagnosis and does not provide any interpretable analytical results.
For further information, warnings and precautions for use, please see the website