Singapore HSA registration DE0509257
Ortho-Clinical VITROS Chemistry Products PHBR Slides
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics Inc·Registered May 06, 2024Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD