Emit® 2000 Procainamide Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® 2000 Procainamide Assay EUDAMEDFDA UDI
- Generic Name
- Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_C_REAG_Procainamide Assay EUDAMEDEmit® 2000 Procainamide Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445320 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_C_REAG_Procainamide Assay EUDAMED
- Description
- Emit® 2000 Procainamide Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 4K229 FDA UDI
- Primary DI / UDI-DI
- 00842768023262 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901293VM EUDAMED
- 510(k) Number
- K010812 FDA UDI
- FDA Product Code
- LAR FDA UDI
- EMDN Code
- W0102080107 PROCAINAMIDE EUDAMED
- GMDN Term
- Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3320 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: Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Procainamide Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
- Procainamide — Roche Diagnostics Corp. · Class II
- ONLINE TDM Procainamide — Roche Diagnostics Corp. · Class II
- Syva® Emit® 2000 Procainamide 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 dcd8d1da-9ca0-43ed-9b9e-622ae5bc4e65 37 fields · synced Jul 16, 2026
- EUDAMED 203271ef-71a7-48dc-ac88-d2a751563f74 61 fields · synced Jul 16, 2026