HSA · registration DE0510078LGC Clinical Diagnostics VALIDATE® DIABETES Calibration Verification / Linearity Test Kit
SingaporeClinical chemistryClass BLGC Clinical Diagnostics, Inc
Official record identity
- Registration number
- DE0510078
- Model name
- VALIDATE® Diabetes Test Set
- Model identifier
- 204ro
- Registration date
- November 27, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- LGC Clinical Diagnostics, Inc
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Official description
VALIDATE Diabetes Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Beta-hydroxybutyrate (BHB)*, C-Peptide (C-PEP), Cystatin C (CYS C), Fructosamine (FRUC) and Insulin (INS).
Additional source fields
- Product owner address
- 221 US-1, Cumberland Foreside, ME, USA, 04110, United States
- Registrant address
- 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674
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.