HSA · registration DE0510617Roche Diagnostics cobas® Ionify Vitamin D 25 and 24,25
- Registration number
- DE0510617
- Model name
- Ionify Vitamin D 25 and 24,25; Ionify CalSet Steroids and Vitamin D; Ionify ControlSet Steroids and Vitamin D
- Model identifier
- 09634622190; 09637273190; 09646965190
- Registration date
- April 22, 2025
- Risk class
- Class B
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
Liquid Chromatography Tandem Mass Spectrometry reagent carrier for the in vitro determination of total 24,25‑dihydroxyvitamin D and total 25‑hydroxyvitamin D in human serum and plasma. The determination of total 24,25‑dihydroxyvitamin D is used as an aid in diagnosis and monitoring of Vitamin D related disorders. The determination of total 25‑hydroxyvitamin D is used for the assessment of Vitamin D sufficiency.
- 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.