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VITROS Chemistry Products ALB Slides - HSA Registration DE0017121

Access comprehensive regulatory information for VITROS Chemistry Products ALB 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 DE0017121 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.

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CLASS B IVD
DE0017121
VITROS Chemistry Products ALB Slides
HSA Registration Number: DE0017121
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Product Description

VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0017121
Registration Date
May 11, 2015
Change Notification Approval Date
July 07, 2020
Retention Due Date
May 10, 2026
Product Owner
Short Name
Ortho-Clinical Diagnostic Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, New York, UNITED STATES
Registrant
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
VITROS Chemistry Products Calibrator Kit 4 VITROS Chemistry Products ALB Slides (Albumin) VITROS Chemistry Products MicroSensor Fluids I & II Chemistry Products Performance Verifier I VITROS Chemistry Products ALB Slides (Albumin) VITROS Chemistry Products Performance Verifier II
Model Identifier(s)
1204668 1988211 6801755 8067324 8196057 8231474