Identity
- Trade Name
- WIESLAB antiGBM, ANCA Screen kit FDA UDI
- Generic Name
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- GCP100 FDA UDI
Identifiers
- Catalog Number
- GCP100 FDA UDI
- Primary DI / UDI-DI
- 07340058410707 FDA UDI
- 510(k) Number
- K981750 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
No
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)
WIESLAB antiGBM, ANCA Screen kit by Euro-Diagnostica AB — 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.
- AESKULISA® PR3 sensitive — Aesku.Diagnostics GmbH & Co. KG · Class II
- 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
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
- Euro-Diagnostica AB
Sources (1)
- FDA UDI a4f5ac4e-00a5-44c6-a244-c325364a2647 34 fields · synced Jun 8, 2026