Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi

The company produces IVD reagents, specifically enzymes and proteins used for clinical chemistry such as alanine aminotransferase (ALT, also called SGPT), lipase, and albumin. These are listed as its most common device categories, indicating the focus is on biochemical assay reagents rather than instruments.

Bioanalytic Diagnostik Kimya is headquartered in Turkey. Its IVD reagents are recorded in the European Union’s Eudamed database, which is the central registry for medical devices and IVDs in the EU. This listing confirms the company’s compliance with the reporting requirements for its product class.

All of the listed reagents – ALT/SGPT, lipase, and albumin – fall under the IVD General classification. This class is used for devices that pose a low to moderate risk and are subject to the general safety and performance requirements of the IVD Regulation, rather than the higher‑risk categories.

The ALT reagent is shown twice because it is marketed under two synonymous names: ALT and SGPT. Both refer to the same enzyme assay, and the duplication reflects the dual labeling rather than indicating separate products.