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Ortho-Clinical VITROS Chemistry Products PHBR Slides - HSA Registration DE0509257

Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products PHBR Slides in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509257 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on May 06, 2024.

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 C IVD
DE0509257
Ortho-Clinical VITROS Chemistry Products PHBR Slides
HSA Registration Number: DE0509257
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Product Description

For in vitro diagnostic and laboratory professional use. VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509257
Registration Date
May 06, 2024
Retention Due Date
May 05, 2026
Product Owner
Short Name
Ortho-Clinical Diagnostics Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, 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 TDM Performance Verifier II VITROS Chemistry Products TDM Performance Verifier III VITROS Chemistry Products PHBR Slides VITROS Chemistry Products Calibrator Kit 9 VITROS Chemistry Products TDM Performance Verifier I
Model Identifier(s)
1792357 8182172 8221384 8568040 8962540