ANA IFA: HEp-20-10

GUDID 04049016045359

EUROIMMUN Medizinische Labordiagnostika AG

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device ID04049016045359
NIH Device Record Key436b5590-88e1-4431-8ae7-4d0a33f429ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA IFA: HEp-20-10
Version Model NumberFA 1522-1010
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
GS104049016045359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, 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 Date2016-09-24

On-Brand Devices [ANA IFA: HEp-20-10]

04049016045403FA 1522-2010
04049016045397FA 1522-2005
04049016045380FA 1522-2003
04049016045366FA 1522-1050
04049016045359FA 1522-1010
04049016045342FA 1522-1005
04049016045335FA 1522-1003

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