UREA UR7976

GUDID 05055273206968

This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.

RANDOX LABORATORIES LIMITED

Urea IVD, reagent
Primary Device ID05055273206968
NIH Device Record Keybe074ef8-7c4f-4cb7-bfd2-4e5fbbe79c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameUREA
Version Model NumberUR7976
Catalog NumberUR7976
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+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Stable for at least 4 weeks in the instrument at approximately +10°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273206968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [UREA]

05055273209600This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206975This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206968This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206951This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206944This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206937This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206920This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206913This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206906This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206869This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273206852This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
05055273216172UR220

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