Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed) EUDAMEDAnti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed) EUDAMEDThe SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome. FDA UDI
- Model / Reference
- A060L EUDAMEDFDA UDI
- Description
- The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-A060LMJ EUDAMED00845533001984 FDA UDI
- Basic UDI-DI
- B-A060LMJ EUDAMED
- 510(k) Number
- K962360 FDA UDI
- FDA Product Code
- MOB FDA UDI
- EMDN Code
- W0102100401 ANCA SCREENING EUDAMED
- GMDN Term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
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 immunoassay
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) by Zeus Scientific, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (2)
- FDA UDI 71f217c0-26f8-4954-a0be-855907f76a54 35 fields · synced Jul 12, 2026
- EUDAMED 3ba0a90f-2415-4d4a-9a99-6bdb8ddf9c44 61 fields · synced Jul 12, 2026