Singapore HSA registration DE0016015
ORGENTEC Diagnostika Alegria ASCA IgA Test Strip
Singapore·CLASS B IVD·ORGENTEC Diagnostika GmbH·Registered July 21, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0016015
- Registration Date
- July 21, 2014
- Change Notification Approval Date
- February 14, 2023
- Retention Due Date
- July 20, 2025
Product description
ASCA IgA is an ELISA-based test system for the quantitative measurement of IgA class anti-Saccharomyces cerevisiae autoantibodies (ASCA) in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only.
Product Owner
- Short Name
- ORGENTEC Diagnostika GmbH
- Address
- Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, GERMANY
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
- Model Name(s)
- ASCA IgA ALEGRIA Positive Control Negative Control
- Model Identifier(s)
- ORG 245A-24 ORG 300-00 ORG 310 ORG 311
About this record
Access comprehensive regulatory information for ORGENTEC Diagnostika Alegria ASCA IgA Test Strip 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 DE0016015 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 21, 2014.
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 B IVD