FDA.reportPublic FDA data

ARK™ Methylphenidate Metabolite Assay

Primary DI
00858724003544
Brand
ARK™ Methylphenidate Metabolite Assay
Company
ARK DIAGNOSTICS INC
Model
5042-0001-00
Catalog number
5042-0001-00
Device description
The ARK™ Methylphenidate Metabolite Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of Methylphenidate Metabolitein human urine at a cutoff concentration of 100 ng/mL.
Published
2018-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003544008587240035448587240035440858724003544

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the amphetamine and/or methamphetamine group(s) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5102706270customersupport@ark-tdm.com

Regulatory Flags#

DUNS number
164880598
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858724003414ARK™ Fentanyl Calibrator5031-0002-005031-0002-002017-04-30
00812101031599ARK™ Ketamine II Assay5083-0001-005083-0001-002025-12-27
00812101031605ARK™ Ketamine II Assay5083-0001-015083-0001-002025-12-27
00812101031612ARK™ Ketamine II Assay5083-0001-025083-0001-022025-12-27
00812101031629ARK™ Ketamine II Calibrator5083-0002-005083-0002-002025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)5083-0002-015083-0002-012025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)5083-0002-025083-0002-022025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)5083-0002-035083-0002-032025-12-27
00812101031667ARK™ Ketamine II Control (25/75)5083-0003-005083-0003-002025-12-27
00812101031674ARK™ Ketamine II Control (75/125)5083-0003-015083-0003-012025-12-27
00812101031995ARK™ Ketamine II Assay5083-0001-035083-0001-032025-12-27
00812101031001DRI Tramadol Assay - 500 mLB40000350B400003502024-11-14
00812101031018DRI Tramadol Assay - 115mLB40000351B400003512024-11-14
00812101031025DRI Tramadol Negative Calibrator KitB40000353B400003532024-11-14
00812101031032DRI Tramadol Cutoff Calibrator KitB40000352B400003522024-11-14
00812101031049DRI Tramadol Calibrator KitB40000366B400003662024-11-14
00812101031056DRI Tramadol Control KitB40000354B400003542024-11-14
00812101031469ARK Levetiracetam II Assay 5070-0001-015070-0001-012024-10-25
00812101030646ARK™ Levetiracetam II Assay 5070-0001-005070-0001-002024-10-24
00812101030653ARK™ Levetiracetam II Calibrator5070-0002-005070-0002-002024-10-24