Pure Global

Microgenics Alinity c Tricyclic Antidepressants - HSA Registration DE0505873

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0505873
Microgenics Alinity c Tricyclic Antidepressants
HSA Registration Number: DE0505873
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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