LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295133912
• Version / Model: 5424296
• Catalog Number: 5424296
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 107b64da-5574-40c1-b2e0-cca384c7f355

Device Description

LDR Early Result Pregnancy Test 2 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: 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
LCX	KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33819	Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)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 within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295133917	GS1	CASE	24	In Commercial Distribution
Primary	00096295133912	GS1
Unit of Use	00633472000126	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042280	000

Storage Conditions

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