Pure Global

ORGENTEC Diagnostika Alegria ASCA IgA Test Strip - HSA Registration DE0016015

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0016015
ORGENTEC Diagnostika Alegria ASCA IgA Test Strip
HSA Registration Number: DE0016015
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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