Singapore HSA registration DE0507318
Abbott Architect NSE
Singapore·CLASS C IVD·Abbott GmbH·Registered September 30, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0507318
- Registration Date
- September 30, 2022
- Change Notification Approval Date
- March 22, 2023
- Retention Due Date
- September 29, 2025
Product description
The NSE assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of neuron-specific enolase (NSE) in human serum on the ARCHITECT i System. The NSE assay is to be used as an aid in the monitoring of response to therapy and detection of recurrent disease, such as small cell lung carcinoma (SCLC) and neuroendocrine tumors.
Product Owner
- Name
- Abbott GmbH
- Short Name
- Abbott GmbH
- Address
- Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- NSE Calibrators NSE Controls NSE Reagent Kit
- Model Identifier(s)
- 06P3201 06P3210 06P3225
About this record
Access comprehensive regulatory information for Abbott Architect NSE 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 DE0507318 and owned by Abbott GmbH. The device was registered on September 30, 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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