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ARK EDDP Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5051-0001-01Model 5051-0001-00
Identity
- Trade Name
- ARK EDDP Assay EUDAMEDARK™ EDDP Assay - 115mL FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent FDA UDI
- Device Name
- ARK EDDP Assay EUDAMEDThe ARK™ EDDP Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of EDDP in human urine at cutoff concentrations of 100ngmL and 300ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5051-0001-00 EUDAMED5051-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ EDDP Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of EDDP in human urine at cutoff concentrations of 100ngmL and 300ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5051-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003858 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003EDDP0515Z EUDAMED
- Direct Marketing DI
- 00858724003858 EUDAMED
- 510(k) Number
- K182779 FDA UDI
- FDA Product Code
- DJR FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3620 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ARK EDDP Assay by Ark Diagnostics Inc — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0858724003EDDP0515Z | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8f6a7202-5007-467b-9e22-b102255c0017 61 fields · synced Jul 23, 2026
- FDA UDI 517cda3c-8802-4245-b7a0-8182f599bb29 37 fields · synced May 24, 2026