Antisera, Hai (Including Hai Control), Rubella
The Rubella HAI (Hemagglutination Inhibition) Antisera (Including HAI Control) are reference reagents used in hemagglutination inhibition tests for the serological detection of rubella virus antibodies, used in immunity screening and acute infection diagnosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GOK, 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
- GOK
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832228 | RUBASCAN LATEX CARD TEST | Sep 29, 1983 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K810835 | RUBAZYME - M | May 05, 1981 | Substantially Equivalent | Abbott Laboratories |
| K792635 | ANTIBODY TO RUBELLA VIRUS | Mar 19, 1980 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K792133 | RUBELISA TEST KIT | Jan 11, 1980 | Substantially Equivalent | Microbiological Assoc. |
| K790122 | RUBANON | Feb 15, 1979 | Substantially Equivalent | Organon, Inc. |
| K781638 | RUBINDEX*DIRECT SYSTEM | Dec 20, 1978 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K781392 | CYTOMEGILISH TEST KIT | Oct 24, 1978 | Substantially Equivalent | Microbiological Assoc. |
| K780063 | RUBENOSTICON | Jan 20, 1978 | Substantially Equivalent | Organon, Inc. |
| K780010 | GOAT ANTI-RUBELLA ANTISERA | Jan 20, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
| K771957 | RUBELLA HEMAGGLUTINATION REAGENT KIT | Oct 28, 1977 | Substantially Equivalent | Flow Laboratories, Inc. |
| K771956 | HUMAN O BUFFER | Oct 28, 1977 | Substantially Equivalent | Flow Laboratories, Inc. |
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.