Fluoro-CheckTM beta-hCG

Basic Information

• Brand Name: Fluoro-CheckTM beta-hCG
• Primary DI: 00895160002519
• Version / Model: TF8146
• Catalog Number: TF8146
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-04-25
• Public Version: 4
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: c952e5ca-5d8f-4a8d-85b1-0c79476662f6

Device Description

An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, 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
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58789	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00895160002519	GS1
Unit of Use	10895160002516	GS1

Customer Contacts

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