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Singapore HSA registration DE0504336

Ortho-Clinical VITROS Chemistry Products hsCRP Assay

Singapore flagSingapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered April 06, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0504336
Registration Date
April 06, 2020
Retention Due Date
April 05, 2026
Product description
VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems to quantitatively measure C-Reactive Protein (CRP) in human serum and plasma.CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.
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 Calibrator Kit 17 VITROS Chemistry Products hsCRP Reagent VITROS Chemistry Products hsCRP Performance Verifier I VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products hsCRP Performance Verifier II VITROS Chemistry Products hsCRP Performance Verifier III
Model Identifier(s)
6801701 6801739 6801742 6801873 6801888 6802049
About this record

Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products hsCRP Assay 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 DE0504336 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on April 06, 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