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Boditech AFIAS PCT Plus G - HSA Registration DE0508873

Access comprehensive regulatory information for Boditech AFIAS PCT Plus G 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 DE0508873 and owned by Boditech Med Inc.. The device was registered on January 22, 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 C IVD
DE0508873
Boditech AFIAS PCT Plus G
HSA Registration Number: DE0508873
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Product Description

AFIAS PCT Plus G is a fluorescence Immunoassay (FIA) for the quantitative determination of PCT (Procalcitonin) in human whole blood/serum/plasma. It is useful as an aid in diagnosis, management and monitoring of bacterial infection and sepsis. For in vitro diagnostic use only.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0508873
Registration Date
January 22, 2024
Retention Due Date
January 21, 2026
Product Owner
Short Name
Boditech Med Inc.
Address
43 Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 23498, KOREA, REPUBLIC OF
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)
Boditech PCT Plus Calibrator Boditech PCT Plus Control AFIAS PCT Plus G
Model Identifier(s)
CFPO-223 CFPO-225 SMFP-112