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LGC Clinical Diagnostics VALIDATE® ANEMIA Calibration Verification / Linearity Test Kit - HSA Registration DE0509540

Access comprehensive regulatory information for LGC Clinical Diagnostics VALIDATE® ANEMIA 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 DE0509540 and owned by LGC Clinical Diagnostics, Inc. The device was registered on July 17, 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.

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CLASS B IVD
DE0509540
LGC Clinical Diagnostics VALIDATE® ANEMIA Calibration Verification / Linearity Test Kit
HSA Registration Number: DE0509540
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Product Description

VALIDATE Anemia 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 on automated instrument systems for the following analytes: ferritin (FERR), folate (FOL) and vitamin B12 (B12)

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509540
Registration Date
July 17, 2024
Retention Due Date
July 16, 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® ANEMIA Calibration Verification / Linearity Test Kit VALIDATE® ANEMIA Calibration Verification / Linearity Test Kit VALIDATE® ANEMIA Calibration Verification / Linearity Test Kit VALIDATE® ANEMIA Calibration Verification / Linearity Test Kit
Model Identifier(s)
308ab 308bc 308re 308vt