Home GUDID 03573026626891 VIDAS® TBI (GFAP, UCH-L1)
Primary DI 03573026626891
Brand VIDAS® TBI (GFAP, UCH-L1)
Company BIOMERIEUX SA
Model VIDAS® TBI (GFAP, UCH-L1)
Device description VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the evaluation of mTBI patients to assist in determining the need for a CT scan
Published 2024-10-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QAT Brain trauma assessment test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QAT Brain Trauma Assessment Test Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03573026626891 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03573026626891 03573026626891 3573026626891
GMDN Terms# Term, Definition table Term Definition Multiple traumatic brain injury marker IVD, kit, fluorescent immunoassay 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 fluorescent 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 276816717 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03573026064532 VIDAS® Measles IgG 30219 2019-08-30 03573026064518 VIDAS® Varicella-Zoster IgG 30217 2016-08-31 03573026610418 VITEK®MS VITEKMS SW v1.0 / FlexPrep v1.0 2019-04-30 03573026644796 VIDAS® Varicella-Zoster IgG 30217-01 2026-01-19 03573026550523 ETEST® Tigecycline (TGC) Etest® TIGECYCLINE 2016-12-12 03573026584139 ID color Catalase ID color Catalase 2019-07-19 03573026092009 ID color Catalase ID color Catalase 2019-07-19 03573026559823 THxID™ BRAF 1.0 2017-05-12 03573026121631 VIDAS® Quality Control 30706 2019-11-19 B0744000160 ASTUTE140 Electronic Quality Control (EQC) Device 400016 400016 2016-08-12 B0745000090 NEPHROCHECK Calibration Verification (Cal Vers) Kit 500009 500009 2016-08-12 B0745000110 NEPHROCHECK Test Kit 500011 500011 2016-08-12 B0745000130 NEPHROCHECK Liquid Control Kit 500013 500013 2016-08-12 03573026547226 ETEST® Ertapenem (ETP) ETEST® Ertapenem (ETP) 2016-11-18 03573026547271 ETEST® Tobramycin (TM) ETEST® Tobramycin (TM) 2016-11-18 03573026547295 ETEST® Tigecycline (TGC) ETEST® Tigecycline (TGC) 2016-11-18 03573026548674 ETEST® Ampicillin/sulbactam (2/1) (AB) ETEST® Ampicillin/sulbactam (2/1) (AB) 2016-11-18 03573026549046 ETEST® Tetracycline (TC) ETEST® Tetracycline (TC) 2016-11-18 03573026549077 ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS) ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS) 2016-11-18 03573026547196 ETEST® Fosfomycin (FM) ETEST® Fosfomycin (FM) 2016-11-18
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