Primary Device ID | 00845533001861 |
NIH Device Record Key | 56832619-a1ee-42de-bfb8-1333fdf40484 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ZEUS dIFine(R) |
Version Model Number | FA08IMG |
Catalog Number | FA08IMG |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
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 | 00845533001861 [Primary] |
JMM | Column Chromatography & Color Development, Hydroxyproline |
PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-11 |
Device Publish Date | 2022-05-03 |
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 |