Identity
- Trade Name
- Myeloperoxidase IgG ELISA FDA UDI
- Generic Name
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG Myeloperoxidase (MPO) IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloperoxidase 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-ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. FDA UDI
- Model / Reference
- EIA-2776 FDA UDI
- Description
- The DRG Myeloperoxidase (MPO) IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloperoxidase 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-ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. FDA UDI
Identifiers
- Catalog Number
- EIA-2776 FDA UDI
- Primary DI / UDI-DI
- 00840239027764 FDA UDI
- 510(k) Number
- K964446 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
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
Yes
FDA UDI
Category: Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)
Myeloperoxidase IgG ELISA by DRG International, Inc. — 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
- AESKULISA® MPO — Aesku.Diagnostics GmbH & Co. KG · 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
Cleared under the same submission
K964446 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
- DRG International, Inc.
Sources (1)
- FDA UDI d136b737-c55b-4cbf-87f2-38b0ff9d8348 37 fields · synced May 30, 2026