POINTE SCIENTIFIC BUN Liquid B7552-150

GUDID 00811727010537

For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Urea IVD, kit, enzyme spectrophotometry
Primary Device ID00811727010537
NIH Device Record Keyba43f03e-fbc6-421a-9739-9909dfc38ce5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOINTE SCIENTIFIC BUN Liquid
Version Model NumberB7552-150
Catalog NumberB7552-150
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
GS100811727010537 [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 BUN Liquid]

00811727010551For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
00811727010544For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
00811727010537For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

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