Anti-Schistosoma mansoni IFA (IgG)

GUDID 04049016101727

EUROIMMUN Medizinische Labordiagnostika AG

Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016101727
NIH Device Record Keyc737ef36-585d-4d61-87ae-f3e9ecf333c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Schistosoma mansoni IFA (IgG)
Version Model NumberFI 2300-1005 G
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104049016101727 [Primary]

FDA Product Code

GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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