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Diagnostica Stago STA® - Deficient XII and STA® - ImmunoDef XII - HSA Registration DE0015529

Access comprehensive regulatory information for Diagnostica Stago STA® - Deficient XII and STA® - ImmunoDef XII 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 DE0015529 and owned by Diagnostica Stago S.A.S. The device was registered on May 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.

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CLASS B IVD
DE0015529
Diagnostica Stago STA® - Deficient XII and STA® - ImmunoDef XII
HSA Registration Number: DE0015529
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Product Description

Intended for use in tests for the determination of factor XII levels in plasma by analyzers of the STA® line suitable to this reagent. These tests require the inclusion of factor XII deficient plasma.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0015529
Registration Date
May 21, 2014
Change Notification Approval Date
March 18, 2025
Retention Due Date
May 20, 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® - ImmunoDef XII STA® - Owren-Koller STA® - CaCl2 0.025 M STA® - Unicalibrator STA® - System Control  N  +  P  STA® - Deficient XII STA® - Microtainer STA® Microcups STA® - Cleaner Solution STA® - Desorb U 1850 ball vial STA® Cuvettes 150 strips of 4 Cuvettes STart® STA-R Evolution® Expert Series STA-R Evolution® Expert Series STA R Max® Cap piercing & STA Coag Expert® STA R Max® & STA Coag Expert® STA R Max® cap piercing STA R Max® STA Compact® STA Compact® STA Compact® STA Compact® STA Compact® CT STA Compact® CT STA Compact Max® STA Compact Max® STA Compact Max® STA Compact Max® STart Max®
Model Identifier(s)
00315 00360 00367 00675 00678 00722 00741 00802 00973 00975 26441 38669 38876 58121 58151 58154 58404 58405 58406 58407 58606 58616 58624 58639 58640 58672 58712 58713 58732 58733 59017