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Abbott Diagnostics Medical Determine™ Syphilis TP - HSA Registration DE0506910

Access comprehensive regulatory information for Abbott Diagnostics Medical Determine™ Syphilis TP 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 DE0506910 and owned by Abbott Diagnostics Medical Co., Ltd.. The device was registered on May 31, 2022.

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
DE0506910
Abbott Diagnostics Medical Determine™ Syphilis TP
HSA Registration Number: DE0506910
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Product Description

Determine™ Syphilis TP is an In Vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, which is the bacteria that causes syphilis infection, in human serum, plasma or whole blood. The test is intended as an aid to detect antibodies to Treponema pallidum from infected individuals.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0506910
Registration Date
May 31, 2022
Change Notification Approval Date
September 20, 2024
Retention Due Date
May 30, 2025
Product Owner
Short Name
Abbott Diagnostics Medical Co., Ltd.
Address
357 Matsuhidai, Matsudo-shi,, Chiba 270-2214,, JAPAN
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model Information
Model Name(s)
Determine™ Chase Buffer Determine™Syphilis TP
Model Identifier(s)
7D2243 7D2443