Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® Ro52 Reagents FDA UDI
- Generic Name
- Ro52 antibody (anti-Ro52)/TRIM21 antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- QUANTA Flash® Ro52 Reagents EUDAMED1. 1 QUANTA Flash Ro52 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipette FDA UDI
- Model / Reference
- 701263 EUDAMEDFDA UDI
- Description
- 1. 1 QUANTA Flash Ro52 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950596523 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950596523 EUDAMED
- 510(k) Number
- K141655 FDA UDI
- FDA Product Code
- OBE FDA UDI
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
- GMDN Term
- Ro52 antibody (anti-Ro52)/TRIM21 antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5100 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
No
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
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 — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950596523 | 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 (2)
- EUDAMED f79b495d-8bec-4bbe-904a-dd8bc1a9928b 61 fields · synced Jul 17, 2026
- FDA UDI 873618e5-de84-48fc-b705-6122c8cbd41a 36 fields · synced May 22, 2026