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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, galactomannan, aspergillus spp.
Definition The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.
Product CodeNOM
Regulation Number 866.3040
Device Class 1


Premarket Reviews
ManufacturerDecision
BIO-RAD
  SUBSTANTIALLY EQUIVALENT 1

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