Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash PR3 Reagents 100T EUDAMEDQUANTA Flash PR3 Reagents EUDAMEDFDA 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 100T EUDAMEDQUANTA Flash PR3 Reagents EUDAMED1. QUANTA Flash PR3 Reagent Cartridge FDA UDI
- Model / Reference
- 701135 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash PR3 Reagent Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950627692 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950627692 EUDAMED84269506276929C 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-08426950627692 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08426950627692 | 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 a724ada1-1825-424e-ab16-1f3d27d2ebe6 61 fields · synced Jul 15, 2026
- EUDAMED e514f307-e2bc-4bc8-b6b5-e9274173deb0 61 fields · synced May 19, 2026
- FDA UDI ae1091e1-cdac-4866-877d-088d28e5ef5f 36 fields · synced May 30, 2026
- EUDAMED 95e249de-94f1-4327-b460-d7b862eef033 61 fields · synced Jun 19, 2026