AIA-PACK CORT Sample Diluting Solution

GUDID 04560189211704

TOSOH CORPORATION

Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent Total cortisol IVD, reagent
Primary Device ID04560189211704
NIH Device Record Key60c2250c-f09b-4aa7-a8ea-5d071a1c81f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIA-PACK CORT Sample Diluting Solution
Version Model NumberN/A
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189211704 [Primary]

FDA Product Code

JFTFluorometric, Cortisol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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