Anti-PR3 2Z9691G

GUDID 00845533002745

The Anti Proteinase-3 (PR-3) is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. This test is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533002745
• NIH Device Record Key: 152df756-ba22-49df-8a73-683afddfacdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-PR3
• Version Model Number: 2Z9691G
• Catalog Number: 2Z9691G
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002745 [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: 2026-01-23
• Device Publish Date: 2026-01-15

On-Brand Devices [Anti-PR3]

• 00845533002752: The Anti Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative d
• 00845533002745: The Anti Proteinase-3 (PR-3) is intended for the qualitative and semi-quantitative detection of