Emit® 2000 Phenytoin Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® 2000 Phenytoin Assay EUDAMEDFDA UDI
- Generic Name
- Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_C_REAG_Phenytoin Assay EUDAMEDEmit® 2000 Phenytoin Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445305 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_C_REAG_Phenytoin Assay EUDAMED
- Description
- Emit® 2000 Phenytoin Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 4A229 FDA UDI
- Primary DI / UDI-DI
- 00842768023217 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901161V3 EUDAMED
- 510(k) Number
- K011347 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 C 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
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: Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Phenytoin Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
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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 3bb63370-da62-4204-8eb3-692183e95fac 37 fields · synced Jul 9, 2026
- EUDAMED 474d4d6e-47bb-4a21-81d4-bbbdfeffe051 61 fields · synced Jul 9, 2026