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Singapore HSA registration DE0510078

LGC Clinical Diagnostics VALIDATE® DIABETES Calibration Verification / Linearity Test Kit

Singapore flagSingapore·CLASS B IVD·LGC Clinical Diagnostics, Inc·Registered November 27, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0510078
Registration Date
November 27, 2024
Retention Due Date
November 26, 2025
Product 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).
Product Owner
Name
LGC Clinical Diagnostics, Inc
Short Name
LGC Clinical Diagnostics, Inc
Address
221 US-1, Cumberland Foreside, ME, USA, 04110, UNITED STATES
Registrant
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
Model Name(s)
VALIDATE® Diabetes Test Set
Model Identifier(s)
204ro
About this record

Access comprehensive regulatory information for LGC Clinical Diagnostics VALIDATE® DIABETES Calibration Verification / Linearity Test Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510078 and owned by LGC Clinical Diagnostics, Inc. The device was registered on November 27, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD