GFAP Reagent Kit 200 Tests


Product Overview

GFAP Reagent Kit 200 Tests
Alinity - 04W1722


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to detect glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) as an aid to determine the need for a neuroimaging radiological scan following head injury.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QAT

    Device Name: Brain Trauma Assessment Test

    Device Class: 2

    Physical State: Assay kit containing antibodies, reagents and plate/or beads. General microplate reader or automated instrument with software

    Definition: Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care

    Submission Type ID: 1

    Review Panel: IM

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Enzyme-linked immunosorbent assay

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Blood

    Regulation Number: 866.5830

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00380740209490

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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