Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® dsDNA Reagents FDA UDI
- Generic Name
- Double stranded DNA antibody (anti-dsDNA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- QUANTA Flash® dsDNA Reagents EUDAMED1 QUANTA Flash dsDNA Reagent Cartridge FDA UDI
- Model / Reference
- 701178 EUDAMEDFDA UDI
- Description
- 1 QUANTA Flash dsDNA Reagent Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950624646 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950624646 EUDAMED
- 510(k) Number
- K152013 FDA UDI
- FDA Product Code
- LSW FDA UDI
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES EUDAMED
- GMDN Term
- Double stranded DNA antibody (anti-dsDNA) 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-08426950624646 | 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 ffe4a8c2-7c4c-4e56-af9e-c61bb8164941 61 fields · synced Jul 15, 2026
- FDA UDI 27f65094-7b04-433a-8c8e-2c9f8ad4b30e 36 fields · synced May 30, 2026