DOA EV3542

GUDID 05055273202397

The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of dr

RANDOX LABORATORIES LIMITED

Multiple drugs of abuse IVD, kit, multiplex
Primary Device ID05055273202397
NIH Device Record Keyb5360c00-28b5-4f5b-8502-ad70cb855f82
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA
Version Model NumberEV3542
Catalog NumberEV3542
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
GS105055273202397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

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]

05055273202397The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative det
05055273202137The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative det

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.