POINTE SCIENTIFIC BUN (Berthelot) B7551-120

GUDID 00811727010568

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

POINTE SCIENTIFIC, INC.

Urea IVD, kit, enzyme spectrophotometry
Primary Device ID00811727010568
NIH Device Record Key3315ed86-013e-48d2-a8eb-67f723c300a9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOINTE SCIENTIFIC BUN (Berthelot)
Version Model NumberB7551-120
Catalog NumberB7551-120
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
GS100811727010568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDLBerthelot Indophenol, 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

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