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Antigen, Galactomannan, Aspergillus Spp.

FDA product code NOM · 4 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3040
Review panel
MI
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2003-05-16 – 2025-08-01

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.

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