Identity
- Trade Name
- Mission Control EUDAMEDMission Control, Level 2 FDA UDIMission Control, Level 1 FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- Mission Control Level 2 EUDAMEDMission Control Level 1 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-92002 EUDAMEDFDA UDIDD-92001 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
- 00811403014750 EUDAMEDFDA UDI00811403014743 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301DD9200296 EUDAMED081140301DD9200194 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 — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301DD9200296 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (4)
- EUDAMED a4857d44-385f-439c-bd36-dddb14825064 61 fields · synced Jul 28, 2026
- FDA UDI c8798a46-703e-43b3-ae89-e5bfc7483f23 33 fields · synced May 29, 2026
- FDA UDI 90c1149c-4a99-4717-b97e-9db879ee1a2c 33 fields · synced May 30, 2026
- EUDAMED cea9fefd-2c30-458f-a710-13ef1d2af5fc 61 fields · synced Jul 28, 2026