Emit® 2000 Carbamazepine Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® 2000 Carbamazepine Assay EUDAMEDFDA UDI
- Generic Name
- Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Assay EUDAMEDEmit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445311 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Assay EUDAMED
- Description
- Emit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 4F229 FDA UDI
- Primary DI / UDI-DI
- 00842768023231 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900203UK EUDAMED
- 510(k) Number
- K010814 FDA UDI
- FDA Product Code
- KLT FDA UDI
- EMDN Code
- W0102080201 CARBAMAZEPINE EUDAMED
- GMDN Term
- Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class C 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
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: Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Carbamazepine Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
- CBZ — Randox Laboratories, Ltd. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Syva® Emit® Carbamazepine Assay — Siemens Healthcare Diagnostics · Class II
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 ac05afed-8dad-4f93-8234-53f7312b9c70 37 fields · synced Aug 4, 2026
- EUDAMED 97d26051-4bf1-4cd6-b347-54291214f932 61 fields · synced Aug 4, 2026