Identity
- Trade Name
- CEDIA Valproic Acid II Assay FDA UDI
- Generic Name
- Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Valproic Acid II EUDAMED
- Model / Reference
- 100013 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001305 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883001305 EUDAMED
- 510(k) Number
- K930734 FDA UDI
- FDA Product Code
- LEG FDA UDI
- EMDN Code
- W0102080210 VALPROIC ACID EUDAMED
- GMDN Term
- Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3645 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Valproic Acid II 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-00884883001305 | 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
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED 591af26b-b2a9-413f-b9a8-1d5e1f907082 61 fields · synced Jul 15, 2026
- FDA UDI ffc7c430-cf0c-4b42-a919-300b91fc0f94 33 fields · synced May 29, 2026