21 CFR 866.3040 — Antigen, Cf, Aspergillus Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3040
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JWT | Antigen, Cf, Aspergillus Spp. | 1 | 5 | |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 1 | 5 | |
| NOM | Antigen, Galactomannan, Aspergillus Spp. | 1 | 4 | 3rd Party |
