Identity
- Trade Name
- ARK EDDP Assay EUDAMEDARK™ EDDP Assay 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 intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5051-0001-00 EUDAMEDFDA UDI
- Description
- The ARK™ EDDP Assay is intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5051-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003841 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003EDDP0515Z EUDAMED
- Direct Marketing DI
- 00858724003841 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 — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182779 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 0858724003EDDP0515Z | Class B | Active |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 9b963252-822e-4de2-a0c5-df64286ef63f 61 fields · synced Jul 29, 2026
- FDA UDI 53a4d75f-307c-478b-93b8-36700d7d550e 37 fields · synced May 29, 2026
- FDA 510(k) K182779 1 fields · synced May 18, 2026