Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
The Indirect Fluorescent Antibody Test, Entamoeba Histolytica and Related Species is an indirect immunofluorescence assay used to detect antibodies against Entamoeba histolytica and related amoebic parasites in patient serum, aiding in the diagnosis of intestinal and extraintestinal amoebiasis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GWD, regulated under 21 CFR 866.3220 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GWD
- Device Class
- FDA class 2
- Regulation Number
- 866.3220
- 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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.