Identity
- Trade Name
- AESKULISA® MPO FDA UDI
- Generic Name
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. FDA UDI
- Model / Reference
- 3303 FDA UDI
- Description
- AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250289501361 FDA UDI
- 510(k) Number
- K091860 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- 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
No
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 anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)
Aeskulisa® Mpo by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA).
- Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- RELISA® MPO-ANCA Antibody Test System — IMMUNO CONCEPTS INC
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Myeloperoxidase IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Anti-MPO ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- QUANTA Lite® MPO SC ELISA — INOVA DIAGNOSTICS, INC. · Class II
- WIESLAB Capture MPO-ANCA — Euro-Diagnostica AB · Class II
Cleared under the same submission
K091860 also covers:
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI db149844-eb0d-4be6-a61b-a70f51b400af 35 fields · synced May 30, 2026