Identity
- Trade Name
- Cyclosporine C2 Control FDA UDI
- Generic Name
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- Cyclosporine C2 Control EUDAMEDMORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood. FDA UDI
- Model / Reference
- 202 EUDAMEDFDA UDI
- Description
- MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood. FDA UDI
Identifiers
- Catalog Number
- 202 FDA UDI
- Primary DI / UDI-DI
- 00856743007055 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856743007MDI020265 EUDAMED
- Direct Marketing DI
- 00856743007055 EUDAMED
- 510(k) Number
- K932662 FDA UDI
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
- GMDN Term
- Cyclosporin A/cyclosporine 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
Yes
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
Cyclosporine C2 Control 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 | 0856743007MDI020265 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- More Diagnostics Inc
- EUDAMED SRN
- US-MF-000019469
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (2)
- EUDAMED cf46be32-b124-4e83-863f-04646a7ec984 61 fields · synced Jul 20, 2026
- FDA UDI 56c07116-5c84-48aa-98de-5d257a0fe0d0 37 fields · synced May 30, 2026