| 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 |
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| 00845533002080 - Fluorescent Treponemal Antibody- Absorption Double Stain (FTA-ABS DS) | 2025-11-19 The Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-trepone |
| 00845533002097 - Fluorescent Treponemal Antibody- Absorption (FTA-ABS) | 2025-11-19 The Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies |
| 00845533002103 - Toxoplasma gondii IgG | 2025-11-19 The Toxoplasma gondii IgG is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vit |
| 00845533002110 - Toxoplasma gondii IgM | 2025-11-19 The Toxoplasma gondii IgM is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM an |
| 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 |