Urea/Bun 08058806190

GUDID 07613336121603

Roche Diagnostics GmbH

Urea IVD, kit, enzyme spectrophotometry
Primary Device ID07613336121603
NIH Device Record Key9fdbd14f-499e-429e-9f34-2aec60212b4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrea/Bun
Version Model Number08058806190
Catalog Number08058806190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336121603 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-13
Device Publish Date2020-03-05

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