Gamma-GT LiquiColor® 2960-500

GUDID 00657498000793

For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry
Primary Device ID00657498000793
NIH Device Record Keye296c9ef-b0fb-4205-b521-a27e0d4be4ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameGamma-GT LiquiColor®
Version Model Number2960-500
Catalog Number2960-500
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS100657498000793 [Primary]

FDA Product Code

JQBKinetic Method, Gamma-Glutamyl Transpeptidase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-16
Device Publish Date2016-09-23

On-Brand Devices [Gamma-GT LiquiColor®]

00657498000793For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or
00657498000786For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or

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