Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
The Equine Encephalitis Virus (EEE, WEE) CF (Complement Fixation) Antisera are reference reagents used in complement fixation tests to detect antibodies against Eastern equine encephalitis (EEE) and Western equine encephalitis (WEE) viruses, mosquito-borne arboviruses that can cause severe neurological disease in humans. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GQC, regulated under 21 CFR 866.3240 in the Microbiology specialty.
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Basic Information
- Product Code
- GQC
- Device Class
- FDA class 1
- Regulation Number
- 866.3240
- 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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.