Pure Global

LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit - HSA Registration DE0509899

Access comprehensive regulatory information for LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509899 and owned by LGC Clinical Diagnostics, Inc. The device was registered on October 11, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0509899
LGC Clinical Diagnostics VALIDATE® Tumor Markers Calibration Verification / Linearity Test Kit
HSA Registration Number: DE0509899
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509899
Registration Date
October 11, 2024
Retention Due Date
October 10, 2025
Product Owner
Short Name
LGC Clinical Diagnostics, Inc
Address
221 US-1, Cumberland Foreside, ME, USA, 04110, UNITED STATES
Registrant
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model Information
Model Name(s)
VALIDATE® Tumor Markers Test Set VALIDATE® Tumor Markers Test Set VALIDATE® Tumor Markers Test Set
Model Identifier(s)
407ab 407re 407sa