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Singapore HSA registration DE0017126

VITROS Chemistry Products dLDL Reagent

Singapore flagSingapore·CLASS B IVD·Ortho-Clinical Diagnostic Inc·Registered May 11, 2015
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0017126
Registration Date
May 11, 2015
Change Notification Approval Date
August 04, 2020
Retention Due Date
May 10, 2026
Product description
VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
Product Owner
Name
Ortho-Clinical Diagnostic Inc
Short Name
Ortho-Clinical Diagnostic Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, New York, UNITED STATES
Registrant
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products dLDL Reagent VITROS Chemistry Products FS Diluent Pack 2 VITROS Chemistry Products MicroSensor Fluids I & II VITROS Chemistry Products FS Calibrator 1 Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II
Model Identifier(s)
6801703 6801728 6801753 6801755 6801873 8067324 8231474
About this record

Access comprehensive regulatory information for VITROS Chemistry Products dLDL Reagent in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0017126 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on May 11, 2015.

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 B IVD