Fluoro-CheckTM D-Dimer

Basic Information

• Brand Name: Fluoro-CheckTM D-Dimer
• Primary DI: 00895160002502
• Version / Model: TF3162
• Catalog Number: TF3162
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-05-24
• Public Version: 2
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 5a7a3d76-7ec7-4494-a82f-658370e2a24b

Device Description

In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma

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
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	864.7320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61389	D-dimer IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein 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	00895160002502	GS1
Unit of Use	10895160002509	GS1

Customer Contacts

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

Storage Conditions

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