Antiserum, Fluorescent, Francisella Tularensis
The Antiserum, Fluorescent, Francisella Tularensis is a fluorescent antiserum used in immunofluorescence laboratory testing to detect Francisella tularensis, the causative agent of tularemia, a potentially serious zoonotic disease. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. The product code is GSJ, regulated under 21 CFR 866.3280 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSJ
- Device Class
- FDA class 2
- Regulation Number
- 866.3280
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | Nov 19, 1991 | Substantially Equivalent | Marlo Surgical Technology |
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.