Identity
- Trade Name
- Anti-PR3-hn-hr ELISA (IgG) FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EA 1201-9601-2 G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016026754 FDA UDI
- 510(k) Number
- K082130 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) 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
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: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
Anti-PR3-hn-hr ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA).
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA PR-3 Test System — ZEUS SCIENTIFIC, INC.
- QUANTA Lite® PR3 SC ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® PR3 SC ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® PR-3 IgG ELISA — INOVA DIAGNOSTICS, INC. · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- ELISA PR-3 Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI a48e5d82-dc89-4646-851c-2672a24a6039 34 fields · synced Jun 1, 2026