Identity
- Trade Name
- CEDIA Phenytoin II Assay FDA UDI
- Generic Name
- Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 100002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001220 FDA UDI
- FDA Product Code
- DIP FDA UDI
- GMDN Term
- Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
CEDIA Phenytoin II Assay by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI 388f79ce-bcb2-40b0-8eef-f961b9b1ecb4 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026