LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295133219
• Version / Model: 5402771
• Catalog Number: 5402771
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-02
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: fe7ff57d-473b-4e4d-bfac-c647bd0d141d

Device Description

LDR Pregnancy Test Analog 1 ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCX	KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54212	Total human chorionic gonadotropin IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295133214	GS1	CASE	24	In Commercial Distribution
Primary	00096295133219	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062703	000