IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR

GUDID 04049016107156

EUROIMMUN Medizinische Labordiagnostika AG

Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay
Primary Device ID04049016107156
NIH Device Record Keyd462d72a-195a-4341-9edf-06c08f9fe3d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameIFA: Crithidia luciliae sensitive (anti-dsDNA) EUR
Version Model NumberFC 1572-1010-1
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
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
GS104049016107156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-26

On-Brand Devices [IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR]

04049016107187FC 1572-2010-1
04049016107156FC 1572-1010-1
04049016107149FC 1572-1005-1

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