Syva® Emit® II Plus Opiate Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® II Plus Opiate Assay EUDAMEDFDA UDISyva® Emit® II Plus Opiate Assay FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Opiate Assay EUDAMEDSyva® Emit® II Plus Opiate Assay - 115 mL Kit FDA UDIEmit® II Plus Opiate Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445415 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Opiate Assay EUDAMED10445416 FDA UDI
- Description
- Syva® Emit® II Plus Opiate Assay - 115 mL Kit FDA UDIEmit® II Plus Opiate Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 9B309UL FDA UDI9B229 FDA UDI
- Primary DI / UDI-DI
- 00842768023354 EUDAMEDFDA UDI00842768001819 FDA UDI
- Basic UDI-DI
- 0405686901152V2 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090113 OPIATES EUDAMED
- GMDN Term
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 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: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Opiate Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 1be738e7-0e5c-4c78-8220-2cb8bc610406 37 fields · synced Jul 29, 2026
- FDA UDI 1bd1546d-8370-4e44-817a-90948033abb4 37 fields · synced May 30, 2026
- EUDAMED d8950d39-cf6d-4576-8bce-c6cf4356e030 61 fields · synced Jul 29, 2026