Singapore HSA registration DE0506910
Abbott Diagnostics Medical Determine™ Syphilis TP
Singapore·CLASS C IVD·Abbott Diagnostics Medical Co., Ltd.·Registered May 31, 2022Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD