Identity
- Trade Name
- IFA: Granulocyte Mosaic 2 FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- FA 1201-1005-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016038979 FDA UDI
- 510(k) Number
- K051489 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay 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 anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
IFA: Granulocyte Mosaic 2 by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051489 also covers:
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 2 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 2 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocyte Mosaic 2 — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocytes (EOH) — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocytes (EOH) — EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocytes (EOH) — EUROIMMUN Medizinische Labordiagnostika AG
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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 574235d9-0048-4175-8320-35877f329f42 34 fields · synced Jun 8, 2026