Identity
- Trade Name
- Mission Control EUDAMEDMission Control, Level 3 FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- Mission Control Level 3 EUDAMEDFor monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart. FDA UDI
- Model / Reference
- DD-92003 EUDAMEDFDA UDI
- Description
- For monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403014767 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301DD9200398 EUDAMED
- FDA Product Code
- JJS FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Multiple blood gas analyte IVD, control FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Hungary 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
No
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
No
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
Mission Control by DIAMOND DIAGNOSTICS Inc — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K033063 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 081140301DD9200398 | Class A | Active |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (3)
- EUDAMED a0963a7d-0712-4c21-a77b-8fa371a99531 61 fields · synced Jul 14, 2026
- FDA UDI 439b9002-c883-4db4-9fdb-ecd698dfb69f 33 fields · synced May 25, 2026
- FDA 510(k) K033063 1 fields · synced May 18, 2026