HSA · registration DE0510497Abbott UroColor 11 Test Strips
- Registration number
- DE0510497
- Model name
- UroColor 11; UroMeter 120; UroMeter 720
- Model identifier
- 10UK11; UM0120; UM0720
- Registration date
- March 25, 2025
- Source update date
- April 09, 2025
- Risk class
- Class B
- Product owner
- Abbott Diagnostics Korea Inc.
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
UroColor provides tests for blood, bilirubin, urobilinogen, ketone, protein, Nitrite, glucose, pH, specific gravity, leucocytes and ascorbic acid in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and urinary tract infection. The UroColor test is for in vitro diagnostic use. It is intended only for professional use in a laboratory setting. The test can be read either visually by a laboratory professional or instrumentally using the UroMeter urine chemistry analyzer
- Product owner address
- 65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, Korea, South
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.