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ARK™ Methotrexate II Assay

FDA UDI

Class U (US FDA UDI)

by Ark Diagnostics Inc

Identity

Trade Name
ARK™ Methotrexate II Assay FDA UDI
Generic Name
Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. FDA UDI
Model / Reference
5071-0001-00 FDA UDI
Description
The ARK™ Methotrexate II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number
5071-0001-00 FDA UDI
Primary DI / UDI-DI
00812101031162 FDA UDI
510(k) Number
K232017 FDA UDI
FDA Product Code
LAO FDA UDI
GMDN Term
Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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, kit, enzyme immunoassay (EIA)

ARK™ Methotrexate II Assay by Ark Diagnostics Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K232017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ark Diagnostics Inc

Sources (1)

  • FDA UDI 95253c1d-9864-4292-890b-410311a50167 37 fields · synced May 31, 2026