NOM · Antigen, Galactomannan, Aspergillus Spp.
Microbiology · 21 CFR 866.3040 · Class 1
Overview
| Product Code | NOM |
|---|---|
| Device Name | Antigen, Galactomannan, Aspergillus Spp. |
| Regulation | 21 CFR 866.3040 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to Aspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | Aug 1, 2025 | SESE |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Bio-Rad | Jan 13, 2011 | SESE |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Bio-Rad | Jun 2, 2006 | SESE |
| K023857 | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 | Bio-Rad | May 16, 2003 | SESE |
Top Applicants
- Bio-Rad — 3 clearances
- Pearl Diagnostics, Inc. — 1 clearance
