Product Code: GOL
FDA class 2
21 CFR 866.3510
Antigen, Ha (Including Ha Control), Rubella
Microbiology
The Rubella HA (Hemagglutination) Antigen (Including HA Control) is a viral antigen reagent used in hemagglutination inhibition tests to detect rubella virus antibodies in patient serum, supporting immunity assessment and diagnosis of rubella infection. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GOL, regulated under 21 CFR 866.3510 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
21
FEI Numbers
0
Registration Numbers
0
Unique Applicants
13
Years Active
8
Research product code GOL in seconds
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Basic Information
- Product Code
- GOL
- 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 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Jun 07, 1984 | Substantially Equivalent | Intl. Diagnostic Technology |
| K834032 | RUBAQUICK DIAGNOSTIC KIT | Apr 17, 1984 | Substantially Equivalent | Abbott Laboratories |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K802508 | RUBELISA IGM TEST KIT | Dec 18, 1980 | Substantially Equivalent | M.A. Bioproducts |
| K802339 | EIA RUBELLA-G | Dec 18, 1980 | Substantially Equivalent | Beckman Instruments, Inc. |
| K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | Dec 18, 1980 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Oct 23, 1980 | Substantially Equivalent | Clinical Assays, Inc. |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | Sep 16, 1980 | Substantially Equivalent | Flow Laboratories, Inc. |
| K801507 | ANTIGEN CONTROL CELLS | Aug 20, 1980 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Jun 30, 1980 | Substantially Equivalent | Litton Bionetics |
| K800797 | MACRO-VUE RUBELLA CARD TEST | Jun 20, 1980 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | Jan 23, 1980 | Substantially Equivalent | Intl. Diagnostic Technology |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent | Litton Bionetics |
| K790976 | RUBAZYME | Aug 16, 1979 | Substantially Equivalent | Abbott Laboratories |
| K790212 | CORDIA T | Apr 12, 1979 | Substantially Equivalent | Cordis Corp. |
| K780885 | CORDIA R | Jan 17, 1979 | Substantially Equivalent | Cordis Corp. |
| K771796 | RUBA-NOST TEST KITS | Oct 18, 1977 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K770809 | MEASLES-FA LABELED PRESERUM (8-441 RNF) | May 20, 1977 | Substantially Equivalent | Flow Laboratories, Inc. |
| K770805 | MEASLES-FA LABELLED (8-441 RF) | May 20, 1977 | Substantially Equivalent | Flow Laboratories, Inc. |
| K770092 | HERPESIVIRUS TEST (TYPE L & 2) | Mar 01, 1977 | Substantially Equivalent | Microbiological Research Corp. |
| K760889 | TEST FOR DETECTION OF ANTIRUBELLA ANTIB | Nov 16, 1976 | Substantially Equivalent | Abbott Laboratories |