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ARK EDDP Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5051-0002-03Model 5051-0001-00
Identity
- Trade Name
- ARK EDDP Calibrator EUDAMEDARK™ EDDP 300 Cutoff Calibrator FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator FDA UDI
- Device Name
- ARK EDDP Assay EUDAMEDARK™ EDDP 300 Cutoff Calibrator is intended for use in calibration of the ARK EDDP Assay. FDA UDI
- Model / Reference
- 5051-0001-00 EUDAMED5051-0002-03 EUDAMEDFDA UDI
- Description
- ARK™ EDDP 300 Cutoff Calibrator is intended for use in calibration of the ARK EDDP Assay. FDA UDI
Identifiers
- Catalog Number
- 5051-0002-03 FDA UDI
- Primary DI / UDI-DI
- 00858724003902 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003EDDP0515Z EUDAMED
- Direct Marketing DI
- 00858724003902 EUDAMED
- 510(k) Number
- K182779 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3200 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 Calibrator 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 d9772c54-9f8d-4a74-a3bf-8ce147f40d2c 61 fields · synced Jun 18, 2026
- FDA UDI 6a574597-cf04-4cfd-959a-abb1da05b16f 37 fields · synced May 25, 2026