Product Code: GWB
FDA class 1
21 CFR 866.3740
Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Microbiology
The Antisera, Fluorescent, All Types, Streptococcus Pneumoniae consists of fluorescent antisera used in immunofluorescence assays to detect and type Streptococcus pneumoniae (pneumococcus) across all capsular types, supporting laboratory diagnosis of pneumococcal infections. It is an FDA Class 1 device subject only to general controls with no premarket notification required. The product code is GWB, regulated under 21 CFR 866.3740 in the Microbiology specialty. No special flags apply to this device.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
16
Basic Information
- Product Code
- GWB
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- 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.