CK Liqui-UV® 2910-430

GUDID 00657498000724

For the Kinetic Quantitative Determination of Creatine Kinase in Serum.

STANBIO LABORATORY, L.P.

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Primary Device ID00657498000724
NIH Device Record Key43553b36-cad8-474f-bb98-89a1552070f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK Liqui-UV®
Version Model Number2910-430
Catalog Number2910-430
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
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

Customer Support Contacts

Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.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
GS100657498000724 [Primary]

FDA Product Code

CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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