NOMClass I
Antigen, Galactomannan, Aspergillus Spp.
21 CFR 866.3040 / Microbiology
NOM is the FDA product code for Antigen, Galactomannan, Aspergillus Spp., a class I device type, regulated under 21 CFR 866.3040. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- NOM
- Device name
- Antigen, Galactomannan, Aspergillus Spp.
- 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.
- Regulation
- 21 CFR 866.3040
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 2
Clearances, product code NOM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code NOM| Applicant | Clearances |
|---|---|
| Bio-Rad | 3 |
| Pearl Diagnostics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.