ENASCREEN ORG506

GUDID 04260157080034

ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS (ena) IN HUMAN SERUM O

ORGENTEC Diagnostika GmbH

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04260157080034
NIH Device Record Key727335b6-4921-47f1-94b5-667098fcc663
Commercial Distribution StatusIn Commercial Distribution
Brand NameENASCREEN
Version Model NumberORG506
Catalog NumberORG506
Company DUNS328133103
Company NameORGENTEC Diagnostika GmbH
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157080034 [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 Date2016-08-31

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