HSA · registration DE0509899

LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit

Name: LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit — HSA DE0509899
Creator: LGC Clinical Diagnostics, Inc
Keywords: LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit, LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit, DE0509899, Clinical chemistry, HSA

SingaporeClinical chemistryClass CLGC Clinical Diagnostics, Inc

Verified

Official record identity

Registration number: DE0509899
Model name: VALIDATE® Tumor Markers Test Set; VALIDATE® Tumor Markers Test Set; VALIDATE® Tumor Markers Test Set
Model identifier: 407ab; 407re; 407sa
Registration date: October 11, 2024

Classification

Risk class: Class C
Published category: Clinical chemistry

Published parties

Product owner: LGC Clinical Diagnostics, Inc
Registrant / registration holder: ALL EIGHTS (SINGAPORE) PRIVATE LIMITED

Official description

VALIDATE Tumor Markers 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 analytes: cancer antigen 15-3 (CA 15-3), cancer antigen 19-9 (CA 19-9), cancer antigen 125 (CA 125) and carcinoembryonic antigen (CEA).

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.