QuikRead go® Instrument 145218

GUDID 06438115000198

QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits.

Orion Diagnostica Oy

Photometric immunoassay analyser IVD
Primary Device ID06438115000198
NIH Device Record Keyc18524c1-7078-4fbf-b950-5e3c1df8abf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuikRead go® Instrument
Version Model Number145218
Catalog Number145218
Company DUNS401656868
Company NameOrion Diagnostica Oy
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+358104261
Emailproduct.support@oriondiagnosti
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu
Phone+358103093000
Emailproduct.support@aidian.eu

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438115000198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2016-06-01

Devices Manufactured by Orion Diagnostica Oy

06438115000006 - Uricult® CLED+Polymyxin / MacConkey2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
06438115000013 - Uricult® CLED+Polymyxin /EMB2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
06438115000020 - Uricult® CLED/MacConkey2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
06438115000037 - Uricult CLED/EMB2020-02-06 A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
06438115000044 - Uricult® Trio2020-02-06 A dip slide culture method for diagnosing urinary tract infections by demonstrating microbes in urine.
06438115000198 - QuikRead go® Instrument2019-03-11QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits.
06438115000198 - QuikRead go® Instrument2019-03-11 QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent
06438115000082 - UniQ® PINP RIA2018-07-06 UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal pro
06438115000099 - QuikRead go® CRP2018-07-06 QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP).

Trademark Results [QuikRead go]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUIKREAD GO
QUIKREAD GO
87287059 5255508 Live/Registered
Orion Diagnostica Oy
2017-01-02

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