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Diagnostica Stago STA® STAClot® DRVV System for Detection of Lupus Anticoagulants - HSA Registration DE0015420

Access comprehensive regulatory information for Diagnostica Stago STA® STAClot® DRVV System for Detection of Lupus Anticoagulants 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 DE0015420 and owned by Diagnostica Stago S.A.S. The device was registered on May 13, 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 B IVD
DE0015420
Diagnostica Stago STA® STAClot® DRVV System for Detection of Lupus Anticoagulants
HSA Registration Number: DE0015420
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Product Description

The STA® - Staclot® dRVV Screen and STA® - Staclot® dRVV Confirm kits are intended for the detection of the lupus anticoagulants (LA) in plasma by the diluted Russell’s viper venom test performed with analyzers of the STA® line suitable to these reagents.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0015420
Registration Date
May 13, 2014
Change Notification Approval Date
March 18, 2022
Retention Due Date
May 12, 2025
Product Owner
Short Name
Diagnostica Stago S.A.S
Address
3 allée Thérésa, 92600 Asnières sur Seine, 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)
STA® - Control LA 1+2 STA® - Staclot® dRVV Screen (5) STA® - Staclot® dRVV Confirm STA® - Staclot® dRVV Screen (2) Pool Norm STA® Microtainer STA® mini Reducer STA® Microcups STA® Cleaner Solution STA® Desorb U STA® Cuvettes STart® STA-R Evolution® Expert Series STA Compact® STA Compact® CT STA Compact Max
Model Identifier(s)
00201 00333 00334 00339 00539 00741 00797 00802 00973 00975 38669 58121 58151/58154 58606/58639/58616/58624 58672/58640 58712/58713/58732/58733