Teco Diagnostics Magnesium Reagent Kit for TC-Matrix M527-430TM

GUDID 10673486002126

Teco Diagnostics Magnesium Reagent Kit for TC-Matrix is used for the quantitative determination of magnesium concentration in serum or plasma on TC-Matrix analyzers.

TECO DIAGNOSTICS

Magnesium (Mg2+) IVD, reagent
Primary Device ID10673486002126
NIH Device Record Keyca5d1bda-7cef-4629-b0d4-867538298da9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Magnesium Reagent Kit for TC-Matrix
Version Model NumberM527-430TM
Catalog NumberM527-430TM
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

Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
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
GS110673486002126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JGJPhotometric Method, Magnesium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-22
Device Publish Date2023-11-14

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