uTASWako Wash Solution 991-60801

GUDID 04987481164505

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Immunohistochemistry wash buffer reagent IVD
Primary Device ID04987481164505
NIH Device Record Keyefb8bc44-c920-417e-aeb8-039a310b5521
Commercial Distribution StatusIn Commercial Distribution
Brand NameuTASWako Wash Solution
Version Model Number991-60801
Catalog Number991-60801
Company DUNS690598875
Company NameFUJIFILM WAKO PURE CHEMICAL CORPORATION
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987481164505 [Unit of Use]
GS110856626006059 [Previous]
GS114987481164502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23

On-Brand Devices [uTASWako Wash Solution]

10856626006059In-Vitro Diagnostic Use
04987481164505In-Vitro Diagnostic Use

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