Identity
- Trade Name
- EUROPLUS Granulocyte Mosaic 25 EUROPattern FDA UDI
- Generic Name
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- FC 1201-2005-25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016108856 FDA UDI
- 510(k) Number
- K172582 FDA UDI
- FDA Product Code
- PIV FDA UDIMVJ FDA UDIMOB FDA UDI
- GMDN Term
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.4750 FDA UDI866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassayGlomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
EUROPLUS Granulocyte Mosaic 25 EUROPattern by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID
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- EUROPLUS Granulocyte Mosaic 25 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG · Class II
Cleared under the same submission
K172582 also covers:
- EUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 25 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 25 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 25 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 32 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 32 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 32 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 32 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- EUROPLUS Granulocyte Mosaic 32 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG
Authorization Coverage (1 country)
Regulatory Authorizations
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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 79538c15-662c-4930-8dfc-cfeec1a4fc52 34 fields · synced Jun 8, 2026