| Primary Device ID | 00845533001571 |
| NIH Device Record Key | c4284891-5e83-4874-8d09-8d0e62ae9ca3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IFA EBV-VCA IgG Test System |
| Version Model Number | FA9151G |
| Catalog Number | FA9151G |
| Company DUNS | 080953946 |
| Company Name | ZEUS SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845533001571 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-24 |
| 00845533002240 - Anti-B. burgdorferi IgG/IgM | 2025-12-17 The Anti-B. burgdorferi IgG/IgM kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of |
| 00845533002257 - Anti-B. burgdorferi IgG/IgM | 2025-12-17 The Anti-B. burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of tot |
| 00845533002264 - Anti-B. burgdorferi IgG/IgM | 2025-12-17 The Anti-B. burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of tot |
| 00845533002271 - Anti-EBV EBNA-1 IgG | 2025-12-17 The Anti-EBV Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG provides a means for the qualitative detection of IgG antibodies |
| 00845533002288 - Anti-EBV EBNA-1 IgG | 2025-12-17 The Anti-EBV Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG provides a means for the qualitative detection of IgG antibodies |
| 00845533002295 - Anti-Jo-1 | 2025-12-17 The Anti-Jo-1 is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1 in human sera. When performed accor |
| 00845533002301 - Anti-Jo-1 | 2025-12-17 The Anti-Jo-1 is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1 in human sera. When performed accor |
| 00845533002318 - Anti-MPO | 2025-12-17 The Anti Myeloperoxidase (MPO) is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloper |