i-STAT TBI cartridge

Basic Information

• Brand Name: i-STAT TBI cartridge
• Primary DI: 00054749005772
• Version / Model: 03S09-25
• Catalog Number: 03S09-25
• Company Name: Abbott Point of Care Inc.
• Labeler DUNS: 116279183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-08
• Public Version: 1
• Public Version Date: 2024-07-16
• Public Version Status: New
• Public Device Record Key: 67b4fc66-b3c7-4d91-ba82-eaf6967cb54c

Device Description

i-STAT TBI cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAT	Brain trauma assessment test	Immunology	866.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66468	Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid electrochemical immunoassay method [excludes immunochromatographic tests (ICT)]. This test is commonly used in the laboratory or in point-of-care analyses 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 scan following head injury. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00054749005772	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K234143	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius