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ARK Meperidine Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5039-0001-01Model 5039-0001-00
Identity
- Trade Name
- ARK Meperidine Assay EUDAMEDARK™ Meperidine Assay FDA UDI
- Generic Name
- Pethidine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Meperidine Assay EUDAMEDThe ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. FDA UDI
- Model / Reference
- 5039-0001-00 EUDAMED5039-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. FDA UDI
Identifiers
- Catalog Number
- 5039-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00812101030134 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003MEP0393B EUDAMED
- Direct Marketing DI
- 00812101030134 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Pethidine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 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 Meperidine 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 | 0858724003MEP0393B | 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 8b91acef-1062-4ff9-be97-276c92283ae4 61 fields · synced Jul 15, 2026
- FDA UDI acf4f504-3670-4a22-a170-7b2e04a29946 36 fields · synced May 30, 2026