LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295141542
• Version / Model: 5741889
• Catalog Number: 5741889
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 17c38be2-1692-4cc6-b9bb-09d384f330d3

Device Description

LDR One Step Pregnancy Test 2 tests

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: Yes
• 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
63245	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)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 within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses for the detection of pregnancy. It is not intended to be used for self-testing.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295141547	GS1	CASE	24	In Commercial Distribution
Primary	00096295141542	GS1
Unit of Use	10096295141549	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984075	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius