ARK™ Ethyl Glucuronide Calibrator 5036-0005-00

GUDID 00858724003636

ARK™ Ethyl Glucuronide Calibrator is intended for use in calibration of the ARK Ethyl Glucuronide Assay.

ARK DIAGNOSTICS INC

Ethyl glucuronide (EtG) IVD, calibrator
Primary Device ID00858724003636
NIH Device Record Key3a6ca071-dbb3-47e9-9899-50ef77993a56
Commercial Distribution StatusIn Commercial Distribution
Brand NameARK™ Ethyl Glucuronide Calibrator
Version Model Number5036-0005-00
Catalog Number5036-0005-00
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
GS100858724003636 [Primary]

FDA Product Code

DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-13
Device Publish Date2018-07-12

On-Brand Devices [ARK™ Ethyl Glucuronide Calibrator]

00858724003636ARK™ Ethyl Glucuronide Calibrator is intended for use in calibration of the ARK Ethyl Glucuron
00858724003483ARK™ Ethyl Glucuronide Calibrator is intended for use in calibration of the ARK Ethyl Glucuron

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