Product Code: GQC FDA class 1 21 CFR 866.3240

Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

Microbiology

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.

510(k)s
2
FEI Numbers
3
Registration Numbers
3
Unique Applicants
1
Years Active
0

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K913618 ARBOVIRUS IGM IFA TEST
K913617 ARBOVIRUS IGG IFA TEST

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.