Fluoro-CheckerTM TRF Reader

Basic Information

• Brand Name: Fluoro-CheckerTM TRF Reader
• Primary DI: 00895160002403
• Version / Model: TRF
• Catalog Number: TF101
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: d67df70c-cec6-4f21-9a13-25569e581067

Device Description

Analyzer for Fluoro-CheckTM line of diagnostic products.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
48014	Fluorescent immunoassay analyser IVD, point-of-care	A portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00895160002403	GS1

Customer Contacts

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