HSA · registration DE0508907Abbott ARCHITECT TBI (GFAP, UCH-L1)
- Registration number
- DE0508907
- Model name
- GFAP Calibrators; GFAP Controls; GFAP Reagent Kit; UCH-L1 Calibrators; UCH-L1 Controls; UCH-L1 Reagent Kit
- Model identifier
- 4W16-01; 4W16-10; 4W16-25; 4W18-01; 4W18-10; 4W18-25
- Registration date
- January 30, 2024
- Risk class
- Class B
- Product owner
- Abbott Ireland Diagnostics Division
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 address
- Finisklin Business Park, Sligo, Ireland
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.