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RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3
FDA UDIIdentity
- Trade Name
- RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- RELISA PR3 Test System - 96 Wells FDA UDI
- Model / Reference
- 7096-16 FDA UDI
- Description
- RELISA PR3 Test System - 96 Wells FDA UDI
Identifiers
- Catalog Number
- 7096-16 FDA UDI
- Primary DI / UDI-DI
- M7497096161 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
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
Yes
FDA UDI
Category: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA).
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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
- Immuno Concepts Inc
Sources (1)
- FDA UDI 8eaf60f7-2bad-4659-b3ee-73715aad5006 34 fields · synced May 31, 2026