Singapore HSA registration DE0508873
Boditech AFIAS PCT Plus G
Singapore·CLASS C IVD·Boditech Med Inc.·Registered January 22, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD