Antiserum, Cf, Epstein-Barr Virus
FDA product code GNP · Class I (low risk) · 21 CFR 866.3235 · Microbiology
20510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Pan Bio Pty. , Ltd. 3
- Amico Lab, Inc. 2
- Diagnostic Technology, Inc. 2
- Granbio, Inc. 2
- Immuno Concepts, Inc. 2
- Diamedix Corp. 2
- Gull Laboratories, Inc. 1
- Electro-Nucleonics Laboratories, Inc. 1
- Biotech Research Laboratories, Inc. 1
- Immuno-Diagnostic Products, Inc. 1
- Microbiological Research Corp. 1
- Hillcrest Biologicals 1
- Electro-Nucleonics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020717 | Ebv V Vca Igm Elisa Kit Model# EBM-200GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020707 | Ebv-Ebna Igg Elisa Kit, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020706 | Ebv-Vca Igg Elisa Test, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K981831 | Is Ebv-Ea-D Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K981829 | Is EBV-EBNA-1 Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K901156 | Eia for Igg Antibody to Ebv Vca in Human SerumGNP · Traditional | Granbio, Inc. | 09/12/1990SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | Electro-Nucleonics, Inc. | 04/28/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | Hillcrest Biologicals | 01/24/1989SE |
| K880885 | Ebv-Vca Igg Antibody Test System (Enzyme)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K880883 | Ebv-Vca Igg Antibody Test System (Fluorescent)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | Diagnostic Technology, Inc. | 06/25/1987SE |
| K864347 | Indirect Immunofluorescent Antibody Assay/ Ebv-VcaGNP · Traditional | Granbio, Inc. | 02/02/1987SE |
| K861121 | The Golden Quad Test (Ebv)GNP · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | Diagnostic Technology, Inc. | 11/28/1986SE |
| K854207 | Ebv(Epstein-Barr Virus) Test KitGNP · Traditional | Immuno-Diagnostic Products, Inc. | 04/24/1986SE |
| K853484 | Indirect Enzyme Linked Immunosorbent Assay Igg AntGNP · Traditional | Biotech Research Laboratories, Inc. | 02/05/1986SE |
| K842662 | Anti-Epstein-Barr Virus KitGNP · Traditional | Amico Lab, Inc. | 12/12/1985SE |
| K842530 | Amizyme-Ebv Test KitGNP · Traditional | Amico Lab, Inc. | 12/06/1985SE |
| K810860 | Eni Antibody to Epstein-Barr VirusGNP · Traditional | Electro-Nucleonics Laboratories, Inc. | 05/05/1981SE |
| K771062 | Ebv TestGNP · Traditional | Gull Laboratories, Inc. | 07/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2574-2018 Class III | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog…Contains a gel-like contaminant that may affect product performance. | Diamedix Corporation | 01/05/2018Terminated |
| Z-1687-2016 Class II | Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…A gel-like substance was found in kit component, sample diluent , that could potentially compromise product… | Diamedix Corporation | 10/20/2014Terminated |