| Primary Device ID | 00845533002004 |
| NIH Device Record Key | 54f21d3a-d14b-4d7d-9fe6-acc116b4dabb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sebia NTx Serum Test System |
| Version Model Number | XJ9021 |
| Catalog Number | XJ9021 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845533002004 [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 | 2025-06-23 |
| Device Publish Date | 2025-06-13 |
| 00845533002004 - Sebia NTx Serum Test System | 2025-06-23An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera. |
| 00845533002004 - Sebia NTx Serum Test System | 2025-06-23 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen |
| 00845533001984 - Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | 2025-06-19 The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in |
| 00845533001991 - Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) | 2025-06-19 Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-AN |
| 00845533001960 - Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | 2025-05-20 The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qua |
| 00845533001977 - Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) | 2025-05-20 The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) test system is an indirect immunofluorescence assay (IFA) for the qu |
| 00845533001953 - ZEUS NTx Serum | 2025-03-31 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen |
| 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 |