NOM — Antigen, Galactomannan, Aspergillus Spp. Class I
Classification Details
- Product Code
- NOM
- Device Class
- Class I
- Regulation Number
- 866.3040
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243496 | pearl diagnostics | MycoMEIA Aspergillus Assay | August 1, 2025 |
| K093678 | bio-rad | PLATELIA ASPERGILLUS EIA MODEL 62793 | January 13, 2011 |
| K060641 | bio-rad | PLATELIA ASPERGILLUS EIA, MODEL 62793 | June 2, 2006 |
| K023857 | bio-rad | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 | May 16, 2003 |