AST (SGOT) KINETIC METHOD TC MATRIX-240/480 A559-780

GUDID 10673486001167

The AST (SGOT) KINETIC METHOD TC MATRIX-240/480 is used for the quantitative determination of aspartate aminotransferase activity in serum or plasma on TC Matrix analyzer.

TECO DIAGNOSTICS

Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent
Primary Device ID10673486001167
NIH Device Record Keycb46b345-fdfb-435b-9ec7-6741e79fa0ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameAST (SGOT) KINETIC METHOD TC MATRIX-240/480
Version Model NumberA559-780
Catalog NumberA559-780
Company DUNS185067774
Company NameTECO DIAGNOSTICS
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

Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.com
Phone714-463-1111
Emailhello@tecodiagnostics.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
GS110673486001167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CITNadh Oxidation/Nad Reduction, Ast/Sgot

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

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