Blackhills Diagnostic Resources S.L.U.

Blackhills Diagnostic Resources S.L.U. specializes in in vitro diagnostic (IVD) test kits designed for genetic and biochemical analysis. Their products include assays for detecting genetic mutations like Factor V G1691A, HFE (C282Y and H63D), and MTHFR (C677T and A1298C), as well as markers for conditions such as lactose intolerance, HLA types (e.g., C*06 and DQA1*05), and biomarkers like PAI-1/FXIII. They also offer screening kits for Fragile X syndrome and spinal cord ataxias (SCAs). These tests are primarily used for human diagnostic purposes in clinical or research settings.

Blackhills Diagnostic Resources S.L.U. is based in Spain, as indicated by the country designation (ES). The company’s location is relevant for regulatory compliance, as it operates within the European Union’s regulatory framework for IVDs.

Blackhills Diagnostic Resources S.L.U.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of IVDs authorized for use within the EU, allowing healthcare professionals, regulators, and patients to verify the legitimacy of the manufacturer’s products.

The company’s devices fall under Class C in vitro diagnostic (IVD) classifications, with some also listed under Annex II List B and the general IVD category. Class C includes tests that pose a higher risk (e.g., those affecting patient management or safety), requiring stricter regulatory scrutiny. Annex II List B applies to certain high-risk IVDs, while the general IVD category covers lower-risk tests like those for genetic markers or biochemical analysis.