Anti-Echinococcus granulosus IFA (IgG)

GUDID 04049016055624

EUROIMMUN Medizinische Labordiagnostika AG

Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016055624
NIH Device Record Key02c4dc3c-d585-44d4-923a-aa505ffcb79b
Commercial Distribution Discontinuation2019-02-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-Echinococcus granulosus IFA (IgG)
Version Model NumberFI 2320-1003 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
GS104049016055624 [Primary]

FDA Product Code

GPDAntigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-15
Device Publish Date2016-09-24

On-Brand Devices [Anti-Echinococcus granulosus IFA (IgG)]

04049016055655FI 2320-2005 G
04049016055648FI 2320-1010 G
04049016055631FI 2320-1005 G
04049016055624FI 2320-1003 G

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