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Emit II Plus Oxycodone Negative Control 300
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 10720811Model IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls
Identity
- Trade Name
- Emit II Plus Oxycodone Negative Control 300 EUDAMEDFDA UDI
- Generic Name
- Oxycodone IVD, control FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls EUDAMEDEmit II Plus Oxycodone Negative Control 300 FDA UDI
- Model / Reference
- 10720811 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls EUDAMED
- Description
- Emit II Plus Oxycodone Negative Control 300 FDA UDI
Identifiers
- Catalog Number
- 9T709UL FDA UDI
- Primary DI / UDI-DI
- 00630414027982 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901154V6 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
- GMDN Term
- Oxycodone IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxycodone IVD, control
Emit II Plus Oxycodone Negative Control 300 by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Oxycodone IVD, control.
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- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- LZI Oxycodone 300 Level 2 Control — Lin-Zhi International, Inc. · Class I
- Oxycodone 100 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 0a36ab02-b4e2-4af1-beb2-da604e1396f6 36 fields · synced Sep 17, 2026
- EUDAMED a67beb1b-4a70-4bcb-9da6-33880ff7fc91 61 fields · synced Sep 17, 2026