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Singapore HSA registration DE0504398

Technoclone TECHNOZYM® ADAMTS-13 Activity ELISA

Singapore flagSingapore·CLASS B IVD·Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH·Registered April 27, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0504398
Registration Date
April 27, 2020
Retention Due Date
April 26, 2026
Product description
The TECHNOZYM® ADAMTS-13 Activity ELISA is a quantitative test for aid in the diagnosis of TTP, using venous-drawn fresh and/or frozen human citrated (3.2% sodium citrate) platelet poor plasma, only when considered in conjunction with other clinical indicators. The assay is performed on microplate readers capable of reading a wavelength of 450 nm. The TECHNOZYM® ADAMTS-13 Activity ELISA is a chromogenic test for measurement of ADAMTS-13 activity. ADAMTS-13 activity measurement serves as an aid in the diagnosis of TTP. The TECHNOZYM® ADAMTS-13 Activity ELISA is intended for prescription use in laboratories by professionals qualified to perform ELISA-based assays.
Product Owner
Name
Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Short Name
Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Address
Brunner Str. 67, 1230 Vienna, AUSTRIA
Registrant
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
Model Name(s)
TECHNOZYM® ADAMTS-13 Activity ELISA TECHNOZYM� ADAMTS-13 Activity Calibration Set TECHNOZYM� ADAMTS-13 Activity Control Set
Model Identifier(s)
5450701 5450761 5450763
About this record

Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 Activity 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 DE0504398 and owned by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. The device was registered on April 27, 2020.

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