CoaguChek XS Patient Self Testing Care Kit 03666794001

GUDID 04015630945689

Roche Diagnostics GmbH

Cancer antigen 15-3 (CA15-3) IVD, antibody
Primary Device ID04015630945689
NIH Device Record Key251487ff-9776-4511-a45f-de28ec6873c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoaguChek XS Patient Self Testing Care Kit
Version Model Number03666794001
Catalog Number03666794001
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Datefalse
Expiration Datefalse
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 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630945689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GJSTest, Time, Prothrombin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-22
Device Publish Date2016-09-24

On-Brand Devices [CoaguChek XS Patient Self Testing Care Kit]

003657021251004837738001
0401563094568903666794001

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