LeadCare® II Blood Lead Testing System 9X Test Kit 70-9000

GUDID 00850355006093

LeadCare® II Blood Lead Testing System 9X Test Kit

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD

• Primary Device ID: 00850355006093
• NIH Device Record Key: a9602d1d-a185-4f8f-81c3-7ce8a200f243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadCare® II Blood Lead Testing System 9X Test Kit
• Version Model Number: LeadCare® II
• Catalog Number: 70-9000
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850355006093 [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: 2016-09-09

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• 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: 2018-07-06LeadCare® II Blood Lead Testing System 9X Test Kit
• 00850355006093 - LeadCare® II Blood Lead Testing System 9X Test Kit: 2018-07-06 LeadCare® II Blood Lead Testing System 9X Test Kit