Identity
- Trade Name
- Mycophenolic Acid Control Level 1 EUDAMEDMPA Control FDA UDI
- Generic Name
- Mycophenolate therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- Mycophenolic Acid Control EUDAMEDMORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. FDA UDI
- Model / Reference
- 240-1 EUDAMEDFDA UDI
- Description
- MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. FDA UDI
Identifiers
- Catalog Number
- 240-1 FDA UDI
- Primary DI / UDI-DI
- 00856743007079 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856743007MDI02406D EUDAMED
- Direct Marketing DI
- 00856743007079 EUDAMED
- 510(k) Number
- K072257 FDA UDI
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
- GMDN Term
- Mycophenolate therapeutic drug monitoring IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Yes
FDA UDI
Mycophenolic Acid Control Level 1 by More Diagnostics Inc — Class C — 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 | 0856743007MDI02406D | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- More Diagnostics Inc
- EUDAMED SRN
- US-MF-000019469
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (2)
- EUDAMED 3c118646-196b-4cfd-b47c-356cde303502 61 fields · synced Jun 1, 2026
- FDA UDI 8fecbdec-3439-4d8c-b7c7-0fe00337dad6 37 fields · synced May 30, 2026