Antisera, Fluorescent, All Types, Escherichia Coli
The Fluorescent Antisera for All Types of Escherichia Coli is a microbiology reagent used to identify and serotype E. coli strains in clinical specimens using fluorescent antibody methods, supporting the diagnosis of enteric and urinary tract infections. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls without a premarket submission requirement. The product code is GMY, regulated under 21 CFR 866.3255 in the Microbiology specialty.
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Basic Information
- Product Code
- GMY
- Device Class
- FDA class 1
- Regulation Number
- 866.3255
- 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.