Antigen, Elisa, Cryptococcus
The Cryptococcus antigen ELISA is a microbiology in vitro diagnostic device used to detect Cryptococcus antigen in patient serum or cerebrospinal fluid, enabling diagnosis of cryptococcal meningitis and disseminated cryptococcosis, particularly in immunocompromised individuals. It is classified as FDA Class II under 21 CFR 866.3165 within the Microbiology specialty, requiring 510(k) premarket clearance. The product code is MDU and the device is not implanted. Full GMP compliance is required.
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Basic Information
- Product Code
- MDU
- Device Class
- FDA class 2
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.