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Singapore HSA registration DE0508907

Abbott ARCHITECT TBI (GFAP, UCH-L1)

Singapore flagSingapore·CLASS B IVD·Abbott Ireland Diagnostics Division·Registered January 30, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508907
Registration Date
January 30, 2024
Retention Due Date
January 29, 2026
Product description
The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the ARCHITECT i System. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan. The TBI test is intended for use in clinical laboratory settings by healthcare professionals.
Product Owner
Name
Abbott Ireland Diagnostics Division
Short Name
Abbott Ireland Diagnostics Division
Address
Finisklin Business Park, Sligo, IRELAND
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
GFAP Calibrators GFAP Controls GFAP Reagent Kit UCH-L1 Calibrators UCH-L1 Controls UCH-L1 Reagent Kit
Model Identifier(s)
4W16-01 4W16-10 4W16-25 4W18-01 4W18-10 4W18-25
About this record

Access comprehensive regulatory information for Abbott ARCHITECT TBI (GFAP, UCH-L1) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508907 and owned by Abbott Ireland Diagnostics Division. The device was registered on January 30, 2024.

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 B IVD