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Singapore HSA registration DE0509235

LGC Clinical Diagnostics VALIDATE® FERTILITY 1 Calibration Verification / Linearity Test Set

Singapore flagSingapore·CLASS B IVD·LGC Clinical Diagnostics, Inc·Registered April 26, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0509235
Registration Date
April 26, 2024
Retention Due Date
April 25, 2026
Product description
VALIDATE Fertility 1 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: follicle-stimulating hormone (FSH), human chorionic gonadotropin (hCG), luteinizing hormone (LH), prolactin (PRL) and testosterone (TSTO)
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® Fertility 1 Test Set VALIDATE® Fertility 1 Test Set
Model Identifier(s)
502ab 502re
About this record

Access comprehensive regulatory information for LGC Clinical Diagnostics VALIDATE® FERTILITY 1 Calibration Verification / Linearity Test Set 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 DE0509235 and owned by LGC Clinical Diagnostics, Inc. The device was registered on April 26, 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