KaliDiv

KaliDiv specializes in diagnostic reagents for parasitology and mycology. Their portfolio includes rapid tests for detecting pathogens like *Plasmodium falciparum*, *Cryptosporidium*, and *Giardia duodenalis*, as well as colorimetric reagents for evaluating procedural performance in parasitological examinations (e.g., *Entamoeba histolytica*). Additionally, they produce colored particulate tracers in liquid or vial formats, designed for microscopy training and quality control purposes.

KaliDiv is headquartered in France, which places its devices under the regulatory scope of the European Union’s Medical Device Regulation (MDR). Since their products are listed in the eudamed database, this confirms they comply with EU requirements for in vitro diagnostics (IVDs). The company’s location ensures alignment with EU MDR classification and registration processes.

KaliDiv’s devices are classified as Class B under the EU Medical Device Regulation (MDR). This classification applies because their products are intended for in vitro diagnostics, such as detecting infectious agents (e.g., parasites) or serving as training aids for microscopy. Class B is assigned to devices with a moderate risk profile, where performance in detecting or identifying pathogens requires validation but does not pose high-risk implications like Class A or higher.

KaliDiv’s devices are registered in the eudamed database, the official EU registry for medical devices and IVDs. Listing in eudamed confirms that the devices meet EU MDR requirements for traceability, transparency, and compliance. Users can verify a device’s registration status here to confirm its legal market authorization within the European Union.

The colored particulate tracers (e.g., KD-TraceColor/PartF, KD-TraceColor/PartB) are designed exclusively for microscopy training and quality control in laboratory settings. They simulate the appearance of pathogens or debris under a microscope, allowing technicians to practice identifying particles and assessing procedural accuracy. These are not intended for direct patient diagnosis but serve as educational tools for improving diagnostic skills.