G7 β-Thalassemia Elution Buffer Kit

GUDID 04560189283503

TOSOH CORPORATION

Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent
Primary Device ID04560189283503
NIH Device Record Keyd8f5a140-fa3d-4c6a-8ee9-17c453240598
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7 β-Thalassemia Elution Buffer Kit
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 Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189283503 [Primary]

FDA Product Code

JPDHemoglobin A2 Quantitation

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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