Dimension® DRUG Calibrator
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dimension® DRUG Calibrator EUDAMEDFDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_C_REAG_DRUG CAL EUDAMEDDrug Calibrator, 2x5x3mL FDA UDI
- Model / Reference
- 10445014 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_C_REAG_DRUG CAL EUDAMED
- Description
- Drug Calibrator, 2x5x3mL FDA UDI
Identifiers
- Catalog Number
- DC22B FDA UDI
- Primary DI / UDI-DI
- 00842768005022 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901260V6 EUDAMED
- Unit of Use DI
- 00630414017112 EUDAMED
- 510(k) Number
- K011035 FDA UDI
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0102152201 TDM/DRUG STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
Yes
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator
Dimension® DRUG Calibrator by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-therapy therapeutic drug monitoring IVD, calibrator.
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- Synchron — Beckman Coulter, Inc. · Class II
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Cleared under the same submission
K011035 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 2b0e51c6-d4c9-44c9-b6d3-54bdcb491a4c 37 fields · synced Oct 6, 2026
- EUDAMED 23363d88-477b-43a5-83a7-e89d284d0113 61 fields · synced Aug 4, 2026