LeadCare® Ultra Blood Lead Testing System 70-8040

GUDID 00850355006055

LeadCare® Ultra Blood Lead Testing System

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD

• Primary Device ID: 00850355006055
• NIH Device Record Key: 0f0785ac-b49e-420c-a585-90c19b1073e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadCare® Ultra Blood Lead Testing System
• Version Model Number: LeadCare® Ultra
• Catalog Number: 70-8040
• 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: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850355006055 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

Devices Manufactured by MAGELLAN DIAGNOSTICS, INC.

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• 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