Fluoro-CheckTM cTnI

Basic Information

• Brand Name: Fluoro-CheckTM cTnI
• Primary DI: 00895160002410
• Version / Model: TF3151
• Catalog Number: TF3151
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 6b7503ad-c20f-4517-86b9-1a04edb2ad4d

Device Description

Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
54010	Troponin I IVD, kit, fluorescent immunoassay	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 a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00895160002410	GS1
Unit of Use	10895160002417	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius