Product code NOM

Device name

Antigen, Galactomannan, Aspergillus Spp.

Medical specialty

Microbiology

Device class

1

Regulation number

866.3040

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset