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Diagnostica Stago Asserachrom® HPIA-IgG - HSA Registration DE0015560

Access comprehensive regulatory information for Diagnostica Stago Asserachrom® HPIA-IgG in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0015560 and owned by Diagnostica Stago S.A.S. The device was registered on May 26, 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.

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CLASS C IVD
DE0015560
Diagnostica Stago Asserachrom® HPIA-IgG
HSA Registration Number: DE0015560
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Product Description

Qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies of IgG class generated during the type II heparin-induced thrombocytopenias (HIT type II) by ELISA.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration Information
Registration Number
DE0015560
Registration Date
May 26, 2014
Change Notification Approval Date
October 28, 2021
Retention Due Date
May 25, 2025
Product Owner
Short Name
Diagnostica Stago S.A.S
Address
9 rue des Freres Chausson, BP 226, 92602 Asnieres sur Seine Cedex, FRANCE
Registrant
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model Information
Model Name(s)
Asserachrom® Washing Solution Asserachrom® HPIA-IgG
Model Identifier(s)
00555 00624