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Immundiagnostik IDKmonitor® Adalimumab total ADA ELISA - HSA Registration DE0508853

Access comprehensive regulatory information for Immundiagnostik IDKmonitor® Adalimumab total ADA ELISA 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 DE0508853 and owned by Immundiagnostik AG. The device was registered on January 16, 2024.

This page provides complete registration details including product owner information, registrant details, 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
DE0508853
Immundiagnostik IDKmonitor® Adalimumab total ADA ELISA
HSA Registration Number: DE0508853
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Product Description

This Immundiagnostik AG assay is an enzyme immunoassay intended for the determination of human antibodies against TNFα blocker adalimumab (e.g. HUMIRA®) in the presence of adalimumab in EDTA plasma and serum. For in vitro diagnostic use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0508853
Registration Date
January 16, 2024
Retention Due Date
January 15, 2026
Product Owner
Short Name
Immundiagnostik AG
Address
Stubenwald-Allee 8a, D‐64625 BENSHEIM, GERMANY
Registrant
Address
1 RAFFLES QUAY, SINGAPORE 048583
Model Information
Model Name(s)
IDKmonitor® Adalimumuab total ADA ELISA
Model Identifier(s)
K 9651