Uricult® CLED+Polymyxin / MacConkey 1003

GUDID 06438115000006

A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.

Orion Diagnostica Oy

Multiple formulation agar culture medium IVD
Primary Device ID06438115000006
NIH Device Record Key7c04e36f-0e0b-4b3e-8606-9adfce617dcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUricult® CLED+Polymyxin / MacConkey
Version Model Number68017
Catalog Number1003
Company DUNS401656868
Company NameOrion Diagnostica Oy
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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+358103093000
Emailproduct.support@oriondiagnostica.fi

Operating and Storage Conditions

Storage Environment TemperatureBetween 7 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 7 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438115000006 [Primary]
GS106438115001058 [Unit of Use]

FDA Product Code

JSICulture Media, Selective And Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-05-13

Devices Manufactured by Orion Diagnostica Oy

06438115000006 - Uricult® CLED+Polymyxin / MacConkey2020-02-06A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
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® Instrument2019-03-11 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 [Uricult]

Mark Image

Registration | Serial
Company
Trademark
Application Date
URICULT
URICULT
72328313 0901995 Live/Registered
LAAKETEHDAS ORION OY
1969-05-26

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