Syva® Emit® II Plus Ethyl Alcohol Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® II Plus Ethyl Alcohol Assay EUDAMEDFDA UDISyva® Emit® II Plus Ethyl Alcohol Assay FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, spectrophotometry FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Assay EUDAMEDSyva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit FDA UDIEmit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445451 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Assay EUDAMED10445446 FDA UDI
- Description
- Syva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit FDA UDIEmit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 9K039UL FDA UDI9K229 FDA UDI
- Primary DI / UDI-DI
- 00842768023439 EUDAMEDFDA UDI00842768014413 FDA UDI
- Basic UDI-DI
- 0405686901107UV EUDAMED
- FDA Product Code
- DML FDA UDIDIC FDA UDI
- EMDN Code
- W0102090207 ETHANOL (ALCOHOL) EUDAMED
- GMDN Term
- Ethanol (ETOH) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3040 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
No
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: Ethanol (ETOH) IVD, kit, spectrophotometry
Syva® Emit® II Plus Ethyl Alcohol Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
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 (3)
- FDA UDI c126417c-3fd1-49f6-adb5-a88ebfcfd640 37 fields · synced Jul 8, 2026
- FDA UDI 0a87f8c3-0be6-4a9e-92ba-5b12a38e844e 37 fields · synced May 30, 2026
- EUDAMED a5769977-5685-4f05-9682-59031e71e710 61 fields · synced Jul 8, 2026