ARK™ EDDP 300 Cutoff Calibrator 5051-0002-03

GUDID 00858724003902

ARK™ EDDP 300 Cutoff Calibrator is intended for use in calibration of the ARK EDDP Assay.

ARK DIAGNOSTICS INC

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Primary Device ID00858724003902
NIH Device Record Key6a574597-cf04-4cfd-959a-abb1da05b16f
Commercial Distribution StatusIn Commercial Distribution
Brand NameARK™ EDDP 300 Cutoff Calibrator
Version Model Number5051-0002-03
Catalog Number5051-0002-03
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
GS100858724003902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-02-21
Device Publish Date2019-01-21

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