Emit II Plus Specialty Multi Drug Calibrator/Control Level 4
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 EUDAMEDFDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug Cals/Ctls Levels 1-4 EUDAMEDEmit II Plus Specialty Multi Drug Calibrator/Control Level 4 FDA UDI
- Model / Reference
- 10720815 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug Cals/Ctls Levels 1-4 EUDAMED
- Description
- Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 FDA UDI
Identifiers
- Catalog Number
- 9T589UL FDA UDI
- Primary DI / UDI-DI
- 00630414027944 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901901VR EUDAMED
- FDA Product Code
- LAS FDA UDIDLJ FDA UDI
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 FDA UDI862.3200 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
Yes
Animal Tissues
No
Microbial Substances
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple drugs of abuse IVD, calibrator
Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 704424a7-60d4-4d24-840f-d6efa6386d49 36 fields · synced Jul 13, 2026
- EUDAMED 26636595-ada3-4b8f-8d15-ec31044c38ae 61 fields · synced Jul 13, 2026