Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Phenytoin EUDAMEDFDA UDI
- Model / Reference
- 5P08-21 EUDAMEDFDA UDI
- Description
- Phenytoin FDA UDI
Identifiers
- Catalog Number
- 05P0821 FDA UDI
- Primary DI / UDI-DI
- 00380740102708 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00380740102708 EUDAMED
- 510(k) Number
- K945725 FDA UDI
- FDA Product Code
- DIP FDA UDI
- EMDN Code
- W0102080208 PHENYTOIN EUDAMED
- GMDN Term
- Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3350 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
No
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
Phenytoin 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-00380740102708 | 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 6467fb18-61c9-40ac-b08c-143737947639 61 fields · synced Jul 24, 2026
- FDA UDI dac6b3f7-ddc7-4b54-8f4f-8a29acbf22f8 37 fields · synced May 30, 2026