AESKULISA® Cardiolipin-Check 7202US

GUDID 04250289503044

AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the comb

Aesku.Diagnostics GmbH & Co. KG

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04250289503044
NIH Device Record Keya3d2c6ae-2380-40fe-a240-096983dd67e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAESKULISA® Cardiolipin-Check
Version Model Number7202US
Catalog Number7202US
Company DUNS341714388
Company NameAesku.Diagnostics GmbH & Co. KG
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250289503044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIDSystem, Test, Anticardiolipin Immunological

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 Date2017-02-28

On-Brand Devices [AESKULISA® Cardiolipin-Check ]

04250289503044AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardio
04250289500821AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardio

Trademark Results [AESKULISA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AESKULISA
AESKULISA
76374617 2878292 Live/Registered
Matthias, Torsten
2002-02-22

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