i-STAT hs-TnI cartridge

Basic Information

• Brand Name: i-STAT hs-TnI cartridge
• Primary DI: 10054749003058
• Version / Model: 09P81-25
• Catalog Number: 09P81-25
• 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: 2025-04-29
• Public Version: 1
• Public Version Date: 2025-05-07
• Public Version Status: New
• Public Device Record Key: 70c2f289-4e05-47ca-9deb-3a68848bda07

Device Description

i-STAT hs-TnI 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: No
• 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
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54009	Troponin I IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00054749003051	GS1	Box	25	In Commercial Distribution
Primary	10054749003058	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240984	000

Storage Conditions

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