ARK™ Methotrexate Assay 5026-0001-00

GUDID 00858724003056

The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.

ARK DIAGNOSTICS INC

Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00858724003056
NIH Device Record Key4a2ab7c4-7751-45cd-a843-5dcc71dda53d
Commercial Distribution StatusIn Commercial Distribution
Brand NameARK™ Methotrexate Assay
Version Model Number5026-0001-00
Catalog Number5026-0001-00
Company DUNS164880598
Company NameARK DIAGNOSTICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5102706270
Emailcustomersupport@ark-tdm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858724003056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAOEnzyme Immunoassay, Methotrexate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [ARK™ Methotrexate Assay]

00858724003254The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitat
00858724003056The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative det
00812101030639The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitat

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