Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)

GUDID 00845533001984

The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome.

ZEUS SCIENTIFIC, INC.

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533001984
• NIH Device Record Key: 71f217c0-26f8-4954-a0be-855907f76a54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
• Version Model Number: A060L
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533001984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962360

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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: 2025-06-19
• Device Publish Date: 2025-06-11

On-Brand Devices [Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)]

• 00845533001960: The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluo
• 00845533001984: The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neut