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Magellan Diagnostics, Inc.
101 Billerica Ave., Bldg 4
N.
Billerica, MA 01862
Phone: 800-305-0197
Information request:
LeadCare@magellandx.com
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www.MagellanDx.com
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COMPANY DESCRIPTION: |
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Magellan Diagnostics proudly delivers
a complete line of FDA-cleared blood lead testing systems. Our flagship
product, the CLIA-waived LeadCare® II system has
revolutionized pediatric lead testing, as real-time results and
preventive education are now a routine part of annual well-child visits.
Two new additions to the product line, LeadCare Ultra®
and LeadCare® Plus™, fulfill the needs of
clinical labs managing annual test volumes from a few hundred to 20,000.
Over 80% of labs currently performing blood lead testing use Magellan
Diagnostics’ systems.
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Test
KIT REQUIREMENTS: |
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Test kit name |
LeadCare II Blood Lead Test Kit |
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CLIA Classification |
CLIA Waived |
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Analytes performed |
Lead |
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CPT Code associated with each analyte |
83655 |
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Test methodology |
Anodic Stripping Voltammetry (ASV) |
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Sample volume |
50 µL |
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Time to result |
3 minutes |
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Units in which the test is reported |
µg/dL |
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MSDS |
LeadCare II Lead Controls, LeadCare Treatment
Reagent
Available upon Request |
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INSTRUMENT REQUIREMENTS: |
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Instrument
name |
LeadCare II Blood Lead Analyzer |
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CLIA Classification |
CLIA Waived |
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Size/Weight/Height |
9.0 in x 6.5 in x 3.5 in.; 2.5 lbs |
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Specifications |
Reportable
range of 3.3-65 µg/dL;
AA batteries or 100-240 volts AC |
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Data Transfer Capability |
N/A |
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Features |
Electronic calibration, pre-packed test kits, portable,
results in 3 minutes |
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Test Menu (Analytes
performed on instrument) |
Lead |
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CPT Code for each Analyte |
83655 |
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Test Methodology |
Electrochemical with disposable sensors |
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Units in which
test results reported |
µg/dL |
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