uTASWako AFP-L3 Calibrator Set 997-60901

GUDID 00856626006168

In-Vitro Diagnostic Use

WAKO LIFE SCIENCES, INC.

Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator
Primary Device ID00856626006168
NIH Device Record Key67d12573-9e50-4ad1-8f0a-e959aa7aae63
Commercial Distribution StatusIn Commercial Distribution
Brand NameuTASWako AFP-L3 Calibrator Set
Version Model Number997-60901
Catalog Number997-60901
Company DUNS078629716
Company NameWAKO LIFE SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856626006168 [Primary]
GS100856626006168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCalibrator, Secondary
JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2016-11-25

Devices Manufactured by WAKO LIFE SCIENCES, INC.

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00856626006151 - CH50 Calibrator2018-07-06 In-Vitro Diagnostic Use
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00085662006168 - μTASWako AFP-L3 Calibrator Set2018-07-06 In-Vitro Diagnostic Use

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