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Singapore HSA registration DE0017134

VITROS Chemistry Products SALI 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
DE0017134
Registration Date
May 11, 2015
Change Notification Approval Date
April 16, 2020
Retention Due Date
May 10, 2026
Product description
VITROS SALI Slides quantitatively measure salicylate (SALI) 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 SALI Slides (Salicylate) VITROS Chemistry Products Liquid Performance Verifier II VITROS Chemistry Products Calibrator Kit 1 VITROS Chemistry Products FS Diluent Pack 2 VITROS Chemistry Products MicroSensor Fluids I & II VITROS Chemistry Products 7% BSA Chemistry Products Liquid Performance Verifier I
Model Identifier(s)
1314343 1384007 1882208 6801753 6801755 8262487 8466492
About this record

Access comprehensive regulatory information for VITROS Chemistry Products SALI 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 DE0017134 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