Antisera, Cf, Rubella
The Rubella CF (Complement Fixation) Antisera are reference reagents used in complement fixation tests to detect and measure antibodies against rubella virus, supporting the diagnosis of acute rubella infection and the evaluation of immune status. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GOM, regulated under 21 CFR 866.3510 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GOM
- Device Class
- FDA class 2
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.