uTASWako DCP 995-60701

GUDID 00856626006120

In-Vitro Diagnostic Use

WAKO LIFE SCIENCES, INC.

Des-gamma-carboxyprothrombin (DCP) IVD, reagent
Primary Device ID00856626006120
NIH Device Record Key69f014f8-f2a2-4660-8e44-8b0ed4958225
Commercial Distribution StatusIn Commercial Distribution
Brand NameuTASWako DCP
Version Model Number995-60701
Catalog Number995-60701
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 Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
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
GS100856626006120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAUDes-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-07

Devices Manufactured by WAKO LIFE SCIENCES, INC.

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00856626006106 - Autokit Micro Albumin Calibrator Set2018-07-06 In-Vitro Diagnostic Use
00856626006113 - Autokit CH502018-07-06 In-Vitro Diagnostic Use
00856626006120 - uTASWako DCP2018-07-06In-Vitro Diagnostic Use
00856626006120 - uTASWako DCP2018-07-06 In-Vitro Diagnostic Use
00856626006151 - CH50 Calibrator2018-07-06 In-Vitro Diagnostic Use
00856626006205 - uTASWako AFP-L32018-07-06 In-Vitro Diagnostic Use
00856626006212 - μTASWako DCP Calibrator Set2018-07-06 In-Vitro Diagnostic Use
00085662006168 - μTASWako AFP-L3 Calibrator Set2018-07-06 In-Vitro Diagnostic Use

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