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HSA · registration DE0505873

Microgenics Alinity c Tricyclic Antidepressants

SingaporeClinical chemistryClass CMicrogenics Corporation
Verified
Official record identity
Registration number
DE0505873
Model name
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
08P6801; 08P6802; 08P6810; 09P91-1A; 09P91-3A; 09P9120
Registration date
June 11, 2021
Source update date
March 26, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Clinical chemistry
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official 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.

Additional source fields
Product owner address
46500 Kato Road, Fremont, CA 94538, CA, United States
Registrant address
3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.