| Primary Device ID | 00845533001953 |
| NIH Device Record Key | d75816fb-b00e-43f1-bcce-227ec2a96016 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZEUS NTx Serum |
| Version Model Number | NTx9021 |
| Catalog Number | XJ9021 |
| Company DUNS | 080953946 |
| Company Name | ZEUS SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845533001953 [Primary] |
| JMM | Column Chromatography & Color Development, Hydroxyproline |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2025-03-21 |
| 00845533002462 - Anti-Cardiolipin IgG | 2025-12-25 The Anti Cardiolipin IgG is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circu |
| 00845533002479 - Anti-H. pylori IgG | 2025-12-25 The Anti Helicobacter pylori IgG is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. p |
| 00845533002486 - Anti-H. pylori IgG | 2025-12-25 The Anti Helicobacter pylori IgG is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. p |
| 00845533002493 - Anti-Borrelia VlsE1/pepC10 IgG/IgM | 2025-12-25 The Anti Borrelia VlsE1/pepC10 IgG/IgM is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pe |
| 00845533002509 - Anti-Borrelia VlsE1/pepC10 IgG/IgM | 2025-12-25 The Anti-Borrelia VlsE1/pepC10 IgG/IgM is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pe |
| 00845533002516 - Anti-T. gondii IgM | 2025-12-25 The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qualitative detection of IgM antibod |
| 00845533002523 - Anti-Cardiolipin IgG | 2025-12-25 The Anti-Cardiolipin IgG is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circu |
| 00845533002530 - Anti-H. pylori IgG | 2025-12-25 The Anti Helicobacter pylori IgG is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. p |