Identity
- Trade Name
- c-ANCA (PR3) ELISA FDA UDI
- Generic Name
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3596 FDA UDI
- Description
- c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3596 FDA UDI
- Primary DI / UDI-DI
- 00840239035967 FDA UDI
- 510(k) Number
- K974702 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
c-ANCA (PR3) ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- DRG International, Inc.
Sources (1)
- FDA UDI 5c9583e7-4c8e-450e-be7a-bb1023065248 38 fields · synced May 29, 2026