Emit® II Plus Amphetamines Assay
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit® II Plus Amphetamines Assay EUDAMEDFDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay EUDAMEDEmit ® II Plus Amphetamines Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445419 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay EUDAMED
- Description
- Emit ® II Plus Amphetamines Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 9C229 FDA UDI
- Primary DI / UDI-DI
- 00842768023361 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900202UH EUDAMED
- 510(k) Number
- K031004 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- EMDN Code
- W0102090101 AMPHETAMINES GROUP EUDAMED
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3100 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: Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Amphetamines Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA).
- Alinity — Abbott Laboratories, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® XTSY RGT KIT Product No. DT423 — Carolina Liquid Chemistries Corp. · Class II
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Ecstasy Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 592b49f6-6f3c-4d37-acbc-47f69d57ab09 37 fields · synced Jul 8, 2026
- EUDAMED f5c60d5f-c6b6-4515-8a8c-f2bb7bd257cc 61 fields · synced Jul 8, 2026