Singapore HSA registration DE0508853
Immundiagnostik IDKmonitor® Adalimumab total ADA ELISA
Singapore·CLASS B IVD·Immundiagnostik AG·Registered January 16, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD