Identity
- Trade Name
- EL-ANCA: anti-PR3 FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-PROTEINASE-3 (PR3) ANTIBODIES (C-ANCA) ELISA TEST KIT, 96 TESTS FDA UDI
- Model / Reference
- 104-115 FDA UDI
- Description
- ANTI-PROTEINASE-3 (PR3) ANTIBODIES (C-ANCA) ELISA TEST KIT, 96 TESTS FDA UDI
Identifiers
- Catalog Number
- 104-115 FDA UDI
- Primary DI / UDI-DI
- 00854473003231 FDA UDI
- 510(k) Number
- K061376 FDA UDI
- GMDN Term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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)
EL-ANCA: anti-PR3 by Theratest Laboratories, Inc. — 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.
- Anti-PR3-hn-hr ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- 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.
Cleared under the same submission
K061376 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI b0394eb2-0e58-4202-8288-e0414598699f 35 fields · synced Jun 8, 2026