Antigen, Ha (Including Ha Control), Rubella
FDA product code GOL · Class II (moderate risk) · 21 CFR 866.3510 · Microbiology
21510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Abbott Laboratories 3
- Flow Laboratories, Inc. 3
- Cordis Corp. 2
- Litton Bionetics 2
- Intl. Diagnostic Technology 2
- Calbiochem-Behring Corp. 2
- Microbiological Research Corp. 1
- Behring Diagnostics, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Ortho Diagnostics, Inc. 1
- Clinical Assays, Inc. 1
- Beckman Instruments, Inc. 1
- M.A. Bioproducts 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | Intl. Diagnostic Technology | 06/07/1984SE |
| K834032 | Rubaquick Diagnostic KitGOL · Traditional | Abbott Laboratories | 04/17/1984SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | Calbiochem-Behring Corp. | 03/11/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | M.A. Bioproducts | 12/18/1980SE |
| K802339 | Eia Rubella-GGOL · Traditional | Beckman Instruments, Inc. | 12/18/1980SE |
| K802102 | Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional | Calbiochem-Behring Corp. | 12/18/1980SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | Clinical Assays, Inc. | 10/23/1980SE |
| K801098 | Enzyme-Immunoassay (Rubella Antibodies)GOL · Traditional | Flow Laboratories, Inc. | 09/16/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | Ortho Diagnostics, Inc. | 08/20/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | Litton Bionetics | 06/30/1980SE |
| K800797 | Macro-Vue Rubella Card TestGOL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/20/1980SE |
| K792249 | Fiax Test Kit for Anti-Rubella AntibodGOL · Traditional | Intl. Diagnostic Technology | 01/23/1980SE |
| K791610 | Rubella Bio-Bead Screen KitGOL · Traditional | Litton Bionetics | 11/13/1979SE |
| K790976 | RubazymeGOL · Traditional | Abbott Laboratories | 08/16/1979SE |
| K790212 | Cordia TGOL · Traditional | Cordis Corp. | 04/12/1979SE |
| K780885 | Cordia RGOL · Traditional | Cordis Corp. | 01/17/1979SE |
| K771796 | Ruba-Nost Test KitsGOL · Traditional | Behring Diagnostics, Inc. | 10/18/1977SE |
| K770809 | Measles-Fa Labeled Preserum (8-441 RNF)GOL · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
| K770805 | Measles-Fa Labelled (8-441 RF)GOL · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
| K770092 | Herpesivirus Test (Type L & 2)GOL · Traditional | Microbiological Research Corp. | 03/01/1977SE |
| K760889 | Test for Detection of Antirubella AntibGOL · Traditional | Abbott Laboratories | 11/16/1976SE |