ST AIA-PACK IgEII

GUDID 14560189210155

TOSOH CORPORATION

Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID14560189210155
NIH Device Record Key829742d5-c8c2-403d-bbc0-3a9d17bb544e
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK IgEII
Version Model NumberN/A
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count5
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
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
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
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189210158 [Unit of Use]
GS114560189210155 [Primary]

FDA Product Code

DGCIge, Antigen, Antiserum, Control

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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