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Singapore HSA registration DE0504647

Ortho-Clinical VITROS Chemistry Products HbA1c Reagent Kit

Singapore flagSingapore·CLASS B IVD·Ortho-Clinical Diagnostic Inc·Registered June 30, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0504647
Registration Date
June 30, 2020
Retention Due Date
June 29, 2025
Product description
For in vitro diagnostic use only. VITROS Chemistry Products HbA1c reagent is used on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
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 %A1c Performance Verifier I VITROS Chemistry Products %A1c Performance Verifier II VITROS Chemistry Products FS Reconstitution Diluent VITROS Chemistry Products HbA1c Reagent Kit VITROS Chemistry Products Calibrator Kit 31
Model Identifier(s)
6801750 6801751 6801874 6842905 6842906
About this record

Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products HbA1c Reagent Kit 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 DE0504647 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on June 30, 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