İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.

İdil Biotech specializes in in vitro diagnostic (IVD) devices focused on nucleic acid extraction, isolation, and qPCR detection. Their products include kits for extracting and isolating nucleic acids from clinical samples, as well as qPCR-based detection kits for infectious diseases. Examples include reagents for transporting cervical specimens, viral transport media, and purification kits for respiratory samples. These devices are designed to identify pathogens like dengue, Zika, chikungunya, Candida species, and Escherichia coli, among others.

İdil Biotech is based in Turkey. Their devices are listed in the EUDAQD database through the eudamed registry, which is the official EU database for medical devices. This registry is used to track and monitor devices that are placed on the market within the European Union.

İdil Biotech’s devices fall under the EU IVD General classification. This classification applies to in vitro diagnostic medical devices that do not pose a high risk to patients or users. The classification is determined based on the intended purpose and potential risk associated with the device, ensuring appropriate regulatory oversight while streamlining the authorization process for lower-risk products.

The primary focus of İdil Biotech’s product portfolio is molecular diagnostics for infectious diseases. Their devices are designed to enable rapid and accurate detection of pathogens through nucleic acid extraction, purification, and qPCR-based testing. This includes solutions for specimen transport, viral transport media, and specialized kits targeting specific pathogens, such as dengue, Zika, and atypical pneumonia pathogens, alongside HLA typing reagents for genetic applications.

İdil Biotech’s devices are registered in eudamed because it is the mandatory EU database for tracking medical devices placed on the market within the European Economic Area (EEA). Registration in eudamed ensures transparency and compliance with EU regulations, allowing authorities, healthcare providers, and patients to access information about the devices, including their classification, manufacturer details, and regulatory status. This is particularly important for IVD devices, which play a critical role in diagnostics and patient care.