Other POC Lead Testing Options

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Does anyone know of any other CLIA-waived POC Lead testing that is available especially with all the Magellan LeadCare Kit issues?

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Hi Mai,
Unfortunately Magellan is the only waived Lead test on the market.  If you check the searchable CLIA database it's the only one that shows up.
CLIA - Clinical Laboratory Improvement Amendments
O FDA Home O Medical Devices O Databases

1 Result found
analyte Name Lead, blood Clia Complexity Waived
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Document Parent Analyte Analyte Specialty Complexity Effective Date
ESA Biosciences LeadCare II Blood Lead Testing System (Whole Blood)
K052549 K052549 Lead, blood Toxicology / TDM WAIVED 09/18/2006


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Mai Vang
about 5 years ago
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