Identity
- Trade Name
- ELISA MPO Test System FDA UDI
- Generic Name
- Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay FDA UDI
- Device Name
- The ZEUS ELISA Myeloperoxidase (MPO) Test System 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 vasculitic 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. FDA UDI
- Model / Reference
- 2Z9671G FDA UDI
- Description
- The ZEUS ELISA Myeloperoxidase (MPO) Test System 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 vasculitic 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. FDA UDI
Identifiers
- Catalog Number
- 2Z9671G FDA UDI
- Primary DI / UDI-DI
- 00845533000840 FDA UDI
- GMDN Term
- Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay
ELISA MPO Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 8bee87f0-edb1-402f-bc77-e0285681c9e5 35 fields · synced May 30, 2026