Biomérieux VIDAS NEPHROCHECK (NEPH) - HSA Registration DE0506823
Access comprehensive regulatory information for Biomérieux VIDAS NEPHROCHECK (NEPH) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506823 and owned by BIOMERIEUX S.A.. The device was registered on April 25, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP‑2 (Tissue Inhibitor of Metalloproteinase‑2) and IGFBP‑7 (Insulin-like Growth Factor‑Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® NEPHROCHECK® assay is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) in acutely ill patients.