LeadCare® Plus Data ManagementSystem 82-0003

GUDID 00850355006116

LeadCare® Plus Data ManagementSystem

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD

• Primary Device ID: 00850355006116
• NIH Device Record Key: 591ec2bc-090c-4ed7-990f-3ab736f934f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadCare® Plus Data ManagementSystem
• Version Model Number: LeadCare®
• Catalog Number: 82-0003
• Company DUNS: 078525694
• Company Name: MAGELLAN DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-275-0102
• Email: LeadCareSupport@magellandx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850355006116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142705

FDA Product Code

• DOF: Lead, Atomic Absorption

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by MAGELLAN DIAGNOSTICS, INC.

• 00850355006086 - LeadCare® II 5X Test Kit: 2018-11-22 LeadCare® II Test Kit 5X Test Kit
• 00850355006185 - LeadCare® Plus Blood Lead Analyzer Kit: 2018-11-22 LeadCare® Plus Blood Lead Analyzer Kit Refurbished
• 00850355006000 - LeadCare® II Blood Lead Test Kit: 2018-07-06 LeadCare® II Blood Lead Test Kit
• 00850355006017 - LeadCare® II Blood Lead Analyzer Kit: 2018-07-06 LeadCare® II Blood Lead Analyzer Kit
• 00850355006031 - LeadCare® Plus Blood Lead Test Kit: 2018-07-06 LeadCare® Plus Blood Lead Test Kit
• 00850355006062 - LeadCare® Plus Blood Lead Analyzer Kit: 2018-07-06 LeadCare® Plus Blood Lead Analyzer Kit
• 00850355006079 - LeadCare® II Blood Lead 6 Tests Kit: 2018-07-06 LeadCare® II Blood Lead 6 Tests Kit
• 00850355006093 - LeadCare® II Blood Lead Testing System 9X Test Kit: 2018-07-06 LeadCare® II Blood Lead Testing System 9X Test Kit