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HSA · registration DE0501509

Ortho-Clinical VITROS Integrated System

SingaporeClinical chemistryClass DOrtho-Clinical Diagnostic Inc
Verified
Official record identity
Registration number
DE0501509
Model name
Vitros 5600 Integrated System; VITROS 5600 Integrated System Refurbished; Vitros XT 7600 Integrated System
Model identifier
6802413; 6802915; 6844461
Registration date
April 12, 2018
Source update date
April 04, 2023
Classification
Risk class
Class D
Official value: CLASS D
Published category
Clinical chemistry
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Published parties
Product owner
Ortho-Clinical Diagnostic Inc
Registrant / registration holder
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official description

For in vitro diagnostic use only. The VITROS Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Additional source fields
Product owner address
100 Indigo Creek Drive, Rochester, New York, 14626, New York, United States
Registrant address
1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.