Antigens, All Groups, Salmonella Spp.
The Antigens, All Groups, Salmonella Spp. is a set of antigens covering all group specificities of Salmonella species, used in laboratory serological testing to identify and serotype Salmonella isolates from clinical and food samples. It is an FDA Class 2 device, reflecting moderate risk and requiring 510(k) premarket clearance before marketing. The product code is GRL, regulated under 21 CFR 866.3550 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GRL
- Device Class
- FDA class 2
- Regulation Number
- 866.3550
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.