Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash PR3 Calibrators EUDAMEDQUANTA Flash® PR3 Calibrators FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, calibrator FDA UDI
- Device Name
- QUANTA Flash® PR3 Calibrators EUDAMEDQUANTA Flash PR3 Calibrators EUDAMED1. QUANTA Flash PR3 Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash PR3 Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
- Model / Reference
- 701136 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash PR3 Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash PR3 Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950554578 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950554578 EUDAMED84269505545789C EUDAMED
- 510(k) Number
- K112545 FDA UDI
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMEDW0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08426950554578 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08426950554578 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 3f6c569a-0bfb-4cf7-8c75-694b4aa2517d 61 fields · synced Aug 3, 2026
- EUDAMED d7012f54-0a41-4830-a14b-ec4b55287ebb 61 fields · synced May 18, 2026
- FDA UDI 56808efd-7865-41d2-8dff-75c3cca38d0b 36 fields · synced May 29, 2026