ARK™ Methotrexate Dilution Buffer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ARK Methotrexate Dilution Buffer EUDAMEDARK™ Methotrexate Dilution Buffer FDA UDI
- Generic Name
- Methotrexate therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- ARK Methotrexate Dilution Buffer EUDAMEDThe ARK™ Methotrexate Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK™ Methotrexate Assay. Its composition is equivalent to the Calibrator A (zero) of ARK™ Methotrexate Calibrator 5026-0002-00. FDA UDI
- Model / Reference
- 5026-0004-00 EUDAMEDFDA UDI
- Description
- The ARK™ Methotrexate Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK™ Methotrexate Assay. Its composition is equivalent to the Calibrator A (zero) of ARK™ Methotrexate Calibrator 5026-0002-00. FDA UDI
Identifiers
- Catalog Number
- 5026-0004-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003209 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003MTX026AJ7 EUDAMED
- Direct Marketing DI
- 00858724003209 EUDAMED
- 510(k) Number
- K111904 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152201 TDM/DRUG STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Methotrexate therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class A 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate Dilution Buffer by Ark Diagnostics Inc — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Methotrexate therapeutic drug monitoring IVD, calibrator.
Cleared under the same submission
K111904 also covers:
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Assay — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Assay (c-pack) — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Calibrator — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
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 |
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Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (2)
- FDA UDI ff00ee33-3452-4545-a3b0-a74861824620 37 fields · synced Jul 29, 2026
- EUDAMED 933cb75f-26da-4009-8d3c-473d0f6ac032 61 fields · synced Jul 29, 2026