HSA · registration DE0509863LGC Clinical Diagnostics VALIDATE® PROCALCITONIN Calibration Verification / Linearity Test Kit
SingaporeClinical chemistryClass CLGC Clinical Diagnostics, Inc
Official record identity
- Registration number
- DE0509863
- Model name
- VALIDATE® PROCALCITONIN Test Set; VALIDATE® PROCALCITONIN Test Set
- Model identifier
- 403ab; 403ro
- Registration date
- October 01, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- LGC Clinical Diagnostics, Inc
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Official description
VALIDATE PROCALCITONIN Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range on automated instrument systems for the following analyte: procalcitonin (PCT).
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.