HSA · registration DE0509769Bio Preventive DNlite-DKD uPTM-FetA ELISA Kit
- Registration number
- DE0509769
- Model name
- DNlite-DKD uPTM-FetA ELISA Kit
- Model identifier
- 8103107
- Registration date
- September 11, 2024
- Risk class
- Class B
- Product owner
- Bio Preventive Medicine Corp.
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
The DNlite-DKD uPTM-FetA ELISA Kit is a colorimetric immunoassay to quantify unique Fetuin-A with specific post translational modification (hereafter referred as E103) in urine. This product is an IVD for prognosis use and should be performed at qualified clinical laboratories by certified medical professionals, such as Medical Technologists. The concentration of E103 should be corrected by urine creatinine before applying to the clinic. The DNlite-DKD uPTM-FetA ELISA Kit is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of kidney function in type 2 diabetes patients with albuminuria.
- Product owner address
- 6F-1., 6F-2., 6F-3., 6F-5., 6F-6., No, 18 Taiyuan St., Zhubei City, Hsinchu County 30265, Taiwan
- Registrant address
- 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
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.