AESKULISA® ß2-Glyco-A 7205US

GUDID 04250289503075

AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative

Aesku.Diagnostics GmbH & Co. KG

Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04250289503075
NIH Device Record Key803d45f3-f428-45a8-b3fb-9fe641af702b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAESKULISA® ß2-Glyco-A
Version Model Number7205US
Catalog Number7205US
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 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 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
GS104250289503075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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 Date2017-03-01

On-Brand Devices [AESKULISA® ß2-Glyco-A]

04250289503075AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I high
04250289502825AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I hi
04250289500852AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I hi

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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