| 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 |
| 00845533002714 - Anti-M. pneumoniae IgG | 2026-01-15 The ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma p |
| 00845533002707 - Human anti-mouse antibody (HAMA) | 2026-01-14 The Human anti-mouse antibody (HAMA) is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of hu |
| 00845533002561 - RF IgM | 2025-12-29 The Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative detection of RF IgM class antib |
| 00845533002578 - RF IgM | 2025-12-29 The Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative detection of RF IgM class antib |
| 00845533002585 - Anti-M. pneumoniae IgG | 2025-12-29 The Anti-M. pneumoniae IgG provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human se |
| 00845533002592 - Anti-M. pneumoniae IgG | 2025-12-29 The Anti-M. pneumoniae IgG provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human se |
| 00845533002608 - Anti-B. burgdorferi IgG | 2025-12-29 The Anti-B. burgdorferi IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG ant |
| 00845533002615 - Anti-B. burgdorferi IgG | 2025-12-29 The Anti-B. burgdorferi IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG ant |