DOA CAL EV3550

GUDID 05055273202458

Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® a

RANDOX LABORATORIES LIMITED

Multiple drugs of abuse IVD, calibrator
Primary Device ID05055273202458
NIH Device Record Keyf7e46e86-0913-4409-beea-f68a3d8d8fb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA CAL
Version Model NumberEV3550
Catalog NumberEV3550
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
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

Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com
Phone+442894422413
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273202458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKBCalibrators, Drug Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [DOA CAL]

05055273207880The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, B
05055273202458Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibratio

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