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TDM Multiconstituent Calibrator
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 5P04-21
Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- TDM Multiconstituent Calibrator EUDAMEDFDA UDI
- Model / Reference
- 5P04-21 EUDAMED5P04-01 FDA UDI
- Description
- TDM Multiconstituent Calibrator FDA UDI
Identifiers
- Catalog Number
- 05P0401 FDA UDI
- Primary DI / UDI-DI
- 00380740101220 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00380740101220 EUDAMED
- 510(k) Number
- K103403 FDA UDI
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
TDM Multiconstituent Calibrator by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00380740101220 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- Thermo Fisher Scientific Oy FI-AR-000028203
Sources (2)
- EUDAMED 3b8f0680-b302-454b-b8ac-ebf8d681fb0f 61 fields · synced Aug 2, 2026
- FDA UDI b883f275-620c-4a64-bbdd-b6c4c3ecbf17 37 fields · synced May 30, 2026