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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mass spectrometric, immunoglobulins (g, a, m, d, e)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Definition The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.
Product CodeSGG
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
THE BINDING SITE GROUP , LTD.
  SUBSTANTIALLY EQUIVALENT 1

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