ARK™ UR-144/JWH-018 Assay 5054-0001-01

GUDID 00812101030257

The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.

ARK DIAGNOSTICS INC

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00812101030257
NIH Device Record Key6c6a7870-5e59-4468-9185-967e4ebf1c33
Commercial Distribution StatusIn Commercial Distribution
Brand NameARK™ UR-144/JWH-018 Assay
Version Model Number5054-0001-01
Catalog Number5054-0001-01
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
GS100812101030257 [Primary]

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-31
Device Publish Date2019-07-23

On-Brand Devices [ARK™ UR-144/JWH-018 Assay]

00812101030257The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of
00812101030240The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of
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