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Singapore HSA registration DE0504943

Ortho-Clinical Diagnostics VITROS Chemistry Products HPT Reagent

Singapore flagSingapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered September 18, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0504943
Registration Date
September 18, 2020
Retention Due Date
September 17, 2025
Product description
VITROS Chemistry Products HPT Reagent is used on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems to quantitatively measure haptoglobin (HPT) concentration in human serum and plasma. The measurement of haptoglobin (HPT) in serum and plasma is used to aid in the detection of intravascular red cell destruction.
Product Owner
Name
Ortho-Clinical Diagnostics Inc
Short Name
Ortho-Clinical Diagnostics Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, 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 HPT Reagent VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT/HPT Performance Verifiers I VITROS Chemistry Products AAT/HPT Performance Verifiers II VITROS Chemistry Products AAT/HPT Performance Verifiers III
Model Identifier(s)
6802214 6802310 6802311 6802312 6802313
About this record

Access comprehensive regulatory information for Ortho-Clinical Diagnostics VITROS Chemistry Products HPT 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 DE0504943 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on September 18, 2020.

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