Pointe Scientific, Inc. Creatinine Enzymatic HC948-480

GUDID 00811727014726

Creatinine Enzymatic Reagent, For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 6 x 60ml, 6 x 20ml

POINTE SCIENTIFIC, INC.

Creatinine IVD, kit, enzyme spectrophotometry
Primary Device ID00811727014726
NIH Device Record Key5fedd003-c7c7-46a9-a808-6758fd0db0df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc. Creatinine Enzymatic
Version Model NumberHC948-480
Catalog NumberHC948-480
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
GS100811727014726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JFYEnzymatic Method, Creatinine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [Pointe Scientific, Inc. Creatinine Enzymatic]

00811727014733Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in seru
00811727014726Creatinine Enzymatic Reagent, For the quantitative enzymatic determination of creatinine in seru

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