Primary Device ID | 00845533001960 |
NIH Device Record Key | 2460fb07-a25f-4979-882c-c881ebeab286 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) |
Version Model Number | FA9601-1010 |
Catalog Number | FA9601-1010 |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
00845533001960 - Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | 2025-05-20The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine®. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFine® must be confirmed by a trained operator. |
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 |
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 |