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Boditech AFIAS Flu A+B - HSA Registration DE0509164

Access comprehensive regulatory information for Boditech AFIAS Flu A+B 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 DE0509164 and owned by Boditech Med Inc.. The device was registered on April 12, 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
DE0509164
Boditech AFIAS Flu A+B
HSA Registration Number: DE0509164
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Product Description

AFIAS Flu A+B is a fluorescence Immunoassay (FIA) for the qualitative determination on influenza infection to detect influenza A and influenza B viral antigen in nasopharyngeal swab specimens taken from symptomatic patients.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0509164
Registration Date
April 12, 2024
Retention Due Date
April 11, 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)
AFIAS Flu A+B
Model Identifier(s)
SMFP-68