Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3). FDA UDI
- Model / Reference
- DACD-1681-2 FDA UDI
- Description
- AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3). FDA UDI
Identifiers
- Catalog Number
- 1681-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000404 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Multiple vasculitis-associated antibody 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: Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA).
- AESKULISA® PR3 sensitive — Aesku.Diagnostics GmbH & Co. KG · Class II
- ELISA ANCA Screen Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ELISA ANCA Screen Test System — ZEUS SCIENTIFIC, INC.
- WIESLAB antiGBM, ANCA Screen kit — Euro-Diagnostica AB · Class II
- AESKULISA® PR3 sensitive — Aesku.Diagnostics GmbH & Co. KG · 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI d7b3d0a4-4cf9-4e6b-85d9-43a39054451b 37 fields · synced May 30, 2026