HSA · registration DE0510547GENTIAN BECKMAN COULTER CYSTATIN C AU Systems
SingaporeClinical chemistryClass BGentian AS
Official record identity
- Registration number
- DE0510547
- Model name
- Gentian Cystatin C Calibrator Kit, level 1-6, vials of 1 mL; Gentian Cystatin C Control Kit, Low & High, vials of 1 m; Gentian Cystatin C Reagent Kit
- Model identifier
- A52763; A52765; B08179
- Registration date
- April 03, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Gentian AS
- Registrant / registration holder
- BECKMAN COULTER SINGAPORE PTE. LTD.
Official description
The Gentian Cystatin C Immunoassay is an immunoturbidimetric assay intended for the in vitro quantitative determination of cystatin C in human serum and plasma on automated clinical analysers by laboratory professional users. The measurement of cystatin C is used in the diagnosis and treatment of renal diseases.
Additional source fields
- Product owner address
- Bjornasveien 5, 1596 Moss Norway, Norway
- Registrant address
- 11 COLLYER QUAY, #05-06C, THE ARCADE, Singapore 049317
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.