AESKULISA® ENA-6S

GUDID 04250289500449

AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigen

Aesku.Diagnostics GmbH & Co. KG

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04250289500449
NIH Device Record Keye4ea7b31-5b95-4cf2-9b7d-d83cdb1cf20d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAESKULISA® ENA-6S
Version Model Number3102
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
GS104250289500449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLLExtractable Antinuclear Antibody, Antigen And Control

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 Date2016-09-27

On-Brand Devices [AESKULISA® ENA-6S ]

04250289502924AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of I
04250289500449AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of I

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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