Antisera, Fluorescent, All Groups, Streptococcus Spp.
The Antisera, Fluorescent, All Groups, Streptococcus Spp. consists of fluorescent-labeled antisera covering all Lancefield groups of Streptococcus species, used in immunofluorescence assays for rapid identification of streptococcal isolates in clinical microbiology laboratories. It is an FDA Class 1 device, subject to general controls only and exempt from premarket notification requirements. The product code is GTX, regulated under 21 CFR 866.3740 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GTX
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- 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.