HSA · registration DE0509894Roche Diagnostics cobas® Online TDM Phenytoin
SingaporeClinical chemistryClass CRoche Diagnostics GmbH
Official record identity
- Registration number
- DE0509894
- Model name
- Preciset ® TDM I; Online TDM Phenytoin; TDM Control Set; Online TDM Phenytoin; Online TDM Phenytoin; Online TDM Phenytoin
- Model identifier
- 03375790190; 04490932190; 04521536190; 05108411190; 08058601190; 08445567190
- Registration date
- October 10, 2024
- Source update date
- April 16, 2026
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
Official description
In vitro test for the quantitative determination of total and free phenytoin in human serum and plasma on cobas c systems. The determination of total and free phenytoin is used in monitoring levels of total and free phenytoin to ensure appropriate therapy
Additional source fields
- Product owner address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
About this record
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.