Pointe Scientific, Inc. BUN OB952-482

GUDID 00811727014955

Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in serum on Olympus Analyzers. For in vitro diagnostic use only. 6 x 66ml, 2 x 43ml

POINTE SCIENTIFIC, INC.

Urea IVD, kit, enzyme spectrophotometry Urea IVD, kit, enzyme spectrophotometry
Primary Device ID00811727014955
NIH Device Record Key3c7e0ecd-ed0a-4b18-8c45-4c84f511a1ba
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc. BUN
Version Model NumberOB952-482
Catalog NumberOB952-482
Company DUNS045623154
Company NamePOINTE SCIENTIFIC, INC.
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 Usefalse
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

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727014955 [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 Date2016-08-31

On-Brand Devices [Pointe Scientific, Inc. BUN]

00811727014955Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in se
00811727014658BUN, for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use

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