HSA · registration DE0510574Roche Diagnostics cobas® Tina-quant Cardiac high sensitivity CRP III
- Registration number
- DE0510574
- Model name
- PreciControl ClinChem Multi 1; PreciControl ClinChem Multi 1; Tina-quant Cardiac high sensitivity CRP III; Tina-quant Cardiac high sensitivity CRP III; Tina-quant Cardiac high sensitivity CRP III; C.f.a.s. Proteins; CRP T Control N
- Model identifier
- 05117003190; 05947626190; 09188231190; 09188240190; 09188266190; 11355279216; 20766321322
- Registration date
- April 10, 2025
- Risk class
- Class C
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
In vitro test for the quantitative determination of C‑reactive protein (CRP) in human serum and plasma on cobas c systems. CRP measurements, performed with this assay, in human serum or plasma, are used as aid in diagnosis, monitoring, prognosis, and management of suspected inflammatory disorders and associated diseases, acute infections and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.
- Product owner address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
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.