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U.S. Department of Health and Human Services

Product Classification

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Device antigen, galactomannan, aspergillus spp.
Regulation Description Aspergillus spp. serological reagents.
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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNOM
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3040
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons