Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) A060PL

GUDID 00845533001991

Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-ANCA and P-ANCA. The P-ANCA pattern shows an uneven granular, staining of the cytoplasm. During the 2nd International ANCA Workshop it was agreed that these two different patterns should be used to subclassify the antibodies. Anti-neutrophil cytoplasmic antibody (ANCA)antibody detection by IFA methods has been a useful aid in the assessment of patient diagnosis, and to a certain extent their prognosis and response to therapy. Although there has been much work done with the IFA ANCA, the availability of an MPO-specific enzyme immunoassay (EIA) test has further enhanced the overall picture. The use of EIA and IFA together allows for the best possible patient assessment. The MPO and PR3 EIA allows for a very quick qualitative as well as quantitative report.

ZEUS SCIENTIFIC, INC.

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

• Primary Device ID: 00845533001991
• NIH Device Record Key: 58bc979a-ab3e-4165-a78c-951a08095e65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)
• Version Model Number: A060PL
• Catalog Number: A060PL
• 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	00845533001991 [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 (Formalin-fixed) ]

• 00845533001977: The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) test system is an indirect immunoflu
• 00845533001991: Standard IFA methods allow for the observation of several different patterns. Two patterns that