Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash PR3 Reagents 50T EUDAMEDQUANTA Flash PR3 Reagents EUDAMEDQUANTA Flash® PR3 Reagents FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- QUANTA Flash® PR3 Reagents EUDAMEDQUANTA Flash PR3 Reagents 50T EUDAMEDQUANTA Flash PR3 Reagents EUDAMED1. 1 QUANTA Flash PR3 Reagent Cartridge FDA UDI
- Model / Reference
- 701138 EUDAMEDFDA UDI
- Description
- 1. 1 QUANTA Flash PR3 Reagent Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950544258 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950544258 EUDAMED84269505442588C EUDAMED
- 510(k) Number
- K112545 FDA UDI
- FDA Product Code
- MOB FDA UDI
- EMDN Code
- W0102100403 PR3 ANCA EUDAMEDW0102100403,W0102109099 EUDAMED
- GMDN Term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 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
Yes
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-08426950544258 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08426950544258 | 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 (4)
- EUDAMED 4dcf7587-5dff-44d5-a9da-11df727513ea 61 fields · synced Jul 25, 2026
- EUDAMED c97d6072-2f48-42f9-82c4-144ca25f4c1b 61 fields · synced May 17, 2026
- FDA UDI d8586f8e-bc64-4710-8479-23a22cd523f4 36 fields · synced May 30, 2026
- EUDAMED ed0f16cf-0207-4de6-a4a1-8d22e1ca96f4 61 fields · synced Jun 19, 2026