Product Code: GRF
FDA class 1
21 CFR 866.3520
Antiserum, Cf, Rubeola
Microbiology
The Antiserum, CF, Rubeola is a complement fixation antiserum used in serological assays to detect and measure antibodies to the rubeola (measles) virus in patient samples. FDA Class 1 designation means it presents the lowest risk, subject only to general controls with no premarket notification required. The product code is GRF, regulated under 21 CFR 866.3520 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
7
Basic Information
- Product Code
- GRF
- Device Class
- FDA class 1
- Regulation Number
- 866.3520
- 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.