Identity
- Trade Name
- ARK™ Methotrexate Calibrator FDA UDI
- Generic Name
- Methotrexate therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/L. FDA UDI
- Model / Reference
- 5026-0002-00 FDA UDI
- Description
- The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/L. FDA UDI
Identifiers
- Catalog Number
- 5026-0002-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003117 FDA UDI
- 510(k) Number
- K111904 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Methotrexate therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate Calibrator by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — 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 Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Control — ARK DIAGNOSTICS INC
- ARK™ Methotrexate Dilution Buffer — ARK DIAGNOSTICS INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (1)
- FDA UDI e62acc79-9c53-445c-bf59-53135677f843 37 fields · synced May 30, 2026