uTASWako Chip Cassette 993-61601

GUDID 10856626006080

The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
Primary Device ID10856626006080
NIH Device Record Keyb0a9243b-d7ca-455f-8382-d91c3eca9219
Commercial Distribution Discontinuation2020-10-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameuTASWako Chip Cassette
Version Model Number993-61601
Catalog Number993-61601
Company DUNS690598875
Company NameFUJIFILM WAKO PURE CHEMICAL CORPORATION
Device Count5
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

Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com
Phone877-714-1924
Emaildiagnostics@wakousa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006083 [Unit of Use]
GS110856626006080 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-10-26
Device Publish Date2016-11-11

On-Brand Devices [uTASWako Chip Cassette]

10856626006080The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.
04987481164420The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.

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