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Quantia IgE Standard
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref 6K50-03
by Biokit S.A.
Identity
- Trade Name
- Quantia IgE Standard EUDAMED
- Device Name
- Quantia IgE EUDAMED
- Model / Reference
- 6K50-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436003070245 EUDAMED
- Basic UDI-DI
- 8436003070238XB EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
New Device
No
EUDAMED
Quantia IgE Standard by Biokit, S.a. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050493 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K214068 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 8436003070238XB | Class B | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED 1d2a3d59-05cb-42c9-980b-b6340da5a0e9 61 fields · synced Jul 29, 2026
- FDA 510(k) K050493 1 fields · synced May 18, 2026