NOM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Galactomannan, Aspergillus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3040
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| MycoMEIA Aspergillus Assay (K243496) | Pearl Diagnostics, Inc. | 2025-08-01 |
| PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678) | Bio-Rad | 2011-01-13 |
| PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641) | Bio-Rad | 2006-06-02 |
| PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857) | Bio-Rad | 2003-05-16 |
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Every clearance here is in the API, with alerts when new ones post.