HSA · registration DE0509257Ortho-Clinical VITROS Chemistry Products PHBR Slides
- Registration number
- DE0509257
- Model name
- 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
- 1792357; 8182172; 8221384; 8568040; 8962540
- Registration date
- May 06, 2024
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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 address
- 100 Indigo Creek Drive, Rochester, New York, 14626, United States
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.