| Primary Device ID | 00845533001809 |
| NIH Device Record Key | 8f9b732a-187f-4a09-a4b4-d8a1d3e691c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZEUS IFA ANA HEp-2 Test System |
| Version Model Number | FA2500A |
| Catalog Number | FA2500A |
| 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 | 00845533001809 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-03 |
| Device Publish Date | 2018-12-03 |
| 00845533001892 - ANA HEp-2 | 2024-12-27 The ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclea |
| 00845533001908 - dsDNA (Crithidia l.) | 2024-12-27 The dsDNA (Crithidia l.) kit is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibod |
| 00845533001915 - Rat Kidney/Stomach Tissue | 2024-12-27 The Rat Kidney/Stomach Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, |
| 00845533001922 - Rat Kidney/Stomach/Liver Tissue | 2024-12-27 The Rat Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochon |
| 00845533001939 - Mouse Kidney/Stomach/Liver Tissue | 2024-12-27 The Mouse Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitoch |
| 00845533001946 - ASA (Monkey Esophagus) | 2024-12-27 The ASA (Monkey Esophagus) kit is designed for the qualitative and semi-quantitative detection of antibodies associated with Pem |
| 00845533001885 - ZEUS ELISA VZV IgM 480 Test System | 2024-09-26 The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuma |
| 00845533001878 - ZEUS NTx Urine | 2023-04-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen |