- Physicians Office Resource

GFAP Reagent Kit 100 Tests
ARCHITECT - 04W1627

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

Handling Environment Temperature - Degrees Celsius

30.00
N/A

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: 00380740213954

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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