Identity
- Trade Name
- ELISA ANCA Screen Test System FDA UDI
- Generic Name
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA ANCA Screen Test System is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The 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 and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 2Z9681G FDA UDI
- Description
- The ZEUS ELISA ANCA Screen Test System is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The 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 and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 2Z9681G FDA UDI
- Primary DI / UDI-DI
- 00845533000154 FDA UDI
- GMDN Term
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) 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: Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
ELISA ANCA Screen Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA).
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- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- PR3 IgG Test System — Scimedx Corp. · Class II
- MBO IgG Test System — Scimedx Corp. · Class II
- WIESLAB ANCA Screen kit — Euro-Diagnostica AB · Class II
- ELISA ANCA Screen Smart Kit Test System — ZEUS SCIENTIFIC, INC.
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 c77f4ae0-6e9b-4000-bdb5-615000ca6abd 35 fields · synced Jun 1, 2026