Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480 A504-780

GUDID 10673486001044

The Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480 is used for the quantitative determination of alkaline phosphatase activity in serum or plasma on TC Matrix analyzers.

TECO DIAGNOSTICS

Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent
Primary Device ID10673486001044
NIH Device Record Key026e513d-d925-458a-b46d-dafee1a797d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480
Version Model NumberA504-780
Catalog NumberA504-780
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
GS110673486001044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-24
Device Publish Date2023-07-14

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