Fluoro-CheckTM Influenza A+B

Basic Information

• Brand Name: Fluoro-CheckTM Influenza A+B
• Primary DI: 00895160002526
• Version / Model: TF8147
• Catalog Number: TF8147
• 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: 2f4d5839-a734-4d4c-bb8b-d9c83ea821a2

Device Description

An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic 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
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	866.3328	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49117	Influenza A/B virus antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus 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	00895160002526	GS1
Unit of Use	10895160002523	GS1

Customer Contacts

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