Anti-MPO

Basic Information

• Brand Name: Anti-MPO
• Primary DI: 00845533002318
• Version / Model: 2Z9671G
• Catalog Number: 2Z9671G
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 6aaab72a-c0dc-449b-a258-d055d5d74704

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
59236	Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of myeloperoxidase (MPO) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533002318	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius