uTASWako i30 991-60301

GUDID 04987481164680

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Electrophoresis analyser IVD, automated
Primary Device ID04987481164680
NIH Device Record Key747bb4d8-075b-4dae-bb3c-6fe3fd51a5d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameuTASWako i30
Version Model Number991-60301
Catalog Number991-60301
Company DUNS690598875
Company NameFUJIFILM WAKO PURE CHEMICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
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
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
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006229 [Previous]
GS104987481164680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUEMicro Total Analysis Instrument System

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 i30]

00856626006229In-Vitro Diagnostic Use
04987481164680In-Vitro Diagnostic Use

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