Product Code: GRJ
FDA class 1
21 CFR 866.3520
Antigen, Cf, (Including Cf Control), Rubeola
Microbiology
The Antigen, CF (Including CF Control), Rubeola is a complement fixation antigen with controls used in serological laboratory testing to detect antibodies to the rubeola (measles) virus. It is classified as FDA Class 1, presenting minimal risk and requiring only general controls without any premarket submission. The product code is GRJ, 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
5
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Basic Information
- Product Code
- GRJ
- 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.