Fluoro-CheckTM CRP Test

Basic Information

• Brand Name: Fluoro-CheckTM CRP Test
• Primary DI: 00895160002670
• Version / Model: TF3163
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: aeb4f9b0-35a7-4d26-a5c3-4fa01f75d157

Device Description

A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.

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
DCN	System, Test, C-Reactive Protein	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58768	C-reactive protein (CRP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10895160002677	GS1
Primary	00895160002670	GS1

Customer Contacts

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