Product Code: GON
FDA class 2
21 CFR 866.3510
Antigen, Cf (Including Cf Control), Rubella
Microbiology
The Rubella CF Antigen (Including CF Control) is a serological reagent used in complement fixation tests to detect rubella antibodies in patient specimens, an important assay for determining rubella immune status and diagnosing infection, especially in pregnancy. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GON, regulated under 21 CFR 866.3510 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
11
Basic Information
- Product Code
- GON
- Device Class
- FDA class 2
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894262 | RUBELLA ANTIGEN AND CONTROL ANTIGEN | Oct 16, 1989 | Substantially Equivalent | MICROBIX BIOSYSTEMS, INC. |
| K880157 | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST | Feb 04, 1988 | Substantially Equivalent | SYVA CO. |
| K802939 | HERPES SIMPLEX TYPE I | Dec 31, 1980 | Substantially Equivalent | ORION DIAGNOSTICA, INC. |
| K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS | Dec 31, 1980 | Substantially Equivalent | ORION DIAGNOSTICA, INC. |
| K780996 | RUBELISA TEST KIT | Nov 22, 1978 | Substantially Equivalent | MICROBIOLOGICAL ASSOC. |