Teco Diagnostics Iron Reagent Kit for TC Matrix I592-380TM

GUDID 10673486002003

Teco Diagnostics Iron Reagent Kit for TC Matrix is used for the quantitative determination of iron concentration in serum on TC Matrix analyzers.

TECO DIAGNOSTICS

Iron IVD, reagent
Primary Device ID10673486002003
NIH Device Record Key5bcb7943-0dba-46a0-84f2-cd62f8c515ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Iron Reagent Kit for TC Matrix
Version Model NumberI592-380TM
Catalog NumberI592-380TM
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
Phone7144631111
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486002003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIYPhotometric Method, Iron (Non-Heme)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-21
Device Publish Date2023-11-13

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