Ortho-Clinical VITROS Immunodiagnostics Products Intact PTH II Reagent Pack - HSA Registration DE0509560
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostics Products Intact PTH II Reagent Pack 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 DE0509560 and owned by Ortho-Clinical Diagnostics. The device was registered on July 22, 2024.
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VITROS Immunodiagnostic Products Intact PTH II Reagent Pack quantitatively measures intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin or sodium heparin) using the automated VITROS ECi/ECiQ/ 3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Intact PTH is indicated to aid in the diagnosis of hyperparathyroidism, hypoparathyroidism, differential diagnosis of hypocalcemia or hypercalcemia and for intraoperative measurement of iPTH levels.