Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
The Enzyme-Linked Immunoabsorbent Assay for Histoplasma capsulatum is an in vitro diagnostic test used to detect antibodies against Histoplasma capsulatum, the fungal pathogen responsible for histoplasmosis, in patient serum to support diagnosis of this systemic fungal infection. Classified as a Class 2 device under 21 CFR 866.3320 in the Microbiology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
Research product code MIZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MIZ
- Device Class
- FDA class 2
- Regulation Number
- 866.3320
- 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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.