Mouse Kidney/Stomach/Liver Tissue FA3403

GUDID 00845533001939

The Mouse Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders and is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533001939
• NIH Device Record Key: 4dd99526-dc24-4065-b560-8ee33d0fcdc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouse Kidney/Stomach/Liver Tissue
• Version Model Number: FA3403
• Catalog Number: FA3403
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533001939 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by ZEUS SCIENTIFIC, INC.

• 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