Singapore HSA registration DE0505873
Microgenics Alinity c Tricyclic Antidepressants
Singapore·CLASS C IVD·Microgenics Corporation·Registered June 11, 2021Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0505873
- Registration Date
- June 11, 2021
- Change Notification Approval Date
- March 26, 2025
- Retention Due Date
- June 10, 2025
Product description
The Alinity c Tricyclic Antidepressants assay is used for the qualitative and semiquantitative determination of tricyclic antidepressants in human serum or plasma using 300 ng/mL as a cutoff calibrator on the Alinity c analyzer.
Product Owner
- Short Name
- Microgenics Corporation
- Address
- 46500 Kato Road, Fremont, CA 94538, CA, UNITED STATES
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)
- Alinity c Tox Semiquant Calibrators Alinity c Tox Qual Calibrators Alinity c Tox Controls Alinity c Tricyclic Antidepressants Assay File Alinity c Tricyclic Antidepressants Assay File Alinity c Tricyclic Antidepressants Reagent Kit
- Model Identifier(s)
- 08P6801 08P6802 08P6810 09P91-1A 09P91-3A 09P9120
About this record
Access comprehensive regulatory information for Microgenics Alinity c Tricyclic Antidepressants 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 DE0505873 and owned by Microgenics Corporation. The device was registered on June 11, 2021.
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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