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Singapore HSA registration DE0017119

VITROS Chemistry Products ACET Slides

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
DE0017119
Registration Date
May 11, 2015
Change Notification Approval Date
April 16, 2020
Retention Due Date
May 10, 2026
Product description
VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma.
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 ACET Slides (Acetaminophen- Paracetamol) VITROS Chemistry Products TDM Performance Verifier II VITROS Chemistry Products FS Diluent Pack 3 VITROS Chemistry Products MicroSensor Fluids I & II VITROS Chemistry Products Specialty Diluent VITROS Chemistry Products Calibrator Kit 9 Chemistry Products TDM Performance Verifier I
Model Identifier(s)
1037274 1792357 6801754 6801755 8559825 8568040 8962540
About this record

Access comprehensive regulatory information for VITROS Chemistry Products ACET Slides 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 DE0017119 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