Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) A506-140

GUDID 10673486001075

The Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method) is used for the direct colorimetric determination of alkaline phosphatase in human serum.

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 ID10673486001075
NIH Device Record Key4bd96318-18cd-4b9e-ae0f-0a749acd1012
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlkaline Phosphatase Reagent Set (Colorimetric Endpoint Method)
Version Model NumberA506-140
Catalog NumberA506-140
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
GS110673486001075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CIOThymolphthalein Monophosphate, 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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