LeadCare® II Blood Lead Test Kit 70-6762

GUDID 00850355006000

LeadCare® II Blood Lead Test Kit

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD

• Primary Device ID: 00850355006000
• NIH Device Record Key: 0140806b-1b5b-44ed-a1c9-deed63a3f823
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadCare® II Blood Lead Test Kit
• Version Model Number: LeadCare® II
• Catalog Number: 70-6762
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850355006000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052549

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

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