Singapore HSA registration DE0509560
Ortho-Clinical VITROS Immunodiagnostics Products Intact PTH II Reagent Pack
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics·Registered July 22, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509560
- Registration Date
- July 22, 2024
- Retention Due Date
- July 21, 2025
Product description
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.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics
- Address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- VITROS Immunodiagnostic Products Intact PTH II Reagent Pack VITROS Immunodiagnostic Products Intact PTH II Calibrators VITROS Immunodiagnostic Products Intact PTH II Controls
- Model Identifier(s)
- 6900052 6900053 6900054
About this record
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.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD