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QUANTA Lite
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 704620Ref 704565510(k) K933180
Identity
- Trade Name
- QUANTA Lite EUDAMED
- Device Name
- QUANTA Lite® C1q CIC ELISA EUDAMEDQUANTA Lite® Anti-C1q ELISA EUDAMED
- Model / Reference
- 704620 EUDAMED704565 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950514190 EUDAMED08426950564164 EUDAMED
- Basic UDI-DI
- B-08426950514190 EUDAMEDB-08426950564164 EUDAMED
- 510(k) Number
- K933180 FDA 510(k)
- FDA Product Code
- DGC FDA 510(k)
- EMDN Code
- W0102010201 COMPLEMENT COMPONENT C1Q EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
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
QUANTA Lite by Inova Diagnostics, Inc. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933180 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08426950514190 | Class IVD General | Active |
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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 5aedfbde-762e-4efc-8f63-7871923bf698 61 fields · synced Jul 25, 2026
- EUDAMED 1b5218c3-b35e-4fb2-a3dc-b7eee12842b0 61 fields · synced May 17, 2026
- FDA 510(k) K933180 24 fields · synced May 18, 2026