FDA Product Code NOM: Antigen, Galactomannan, Aspergillus Spp.
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.
Leading manufacturers include Pearl Diagnostics, Inc..
FDA 510(k) Cleared Antigen, Galactomannan, Aspergillus Spp. Devices (Product Code NOM)
About Product Code NOM - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code NOM since 2003, with 4 receiving FDA clearance (average review time: 234 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NOM have taken an average of 262 days to reach a decision - up from 224 days historically. Manufacturers should account for longer review timelines in current project planning.
NOM devices are reviewed by the Microbiology panel. Browse all Microbiology devices →