Anti-Adenovirus IFA (IgM)

GUDID 04049016059455

EUROIMMUN Medizinische Labordiagnostika AG

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016059455
NIH Device Record Key53158993-d618-4bf1-aa3a-d4daea6bd41f
Commercial Distribution Discontinuation2018-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-Adenovirus IFA (IgM)
Version Model NumberFI 2680-2005 M
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
GS104049016059455 [Primary]

FDA Product Code

GNYAntisera, Fluorescent, Adenovirus 1-33

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-14
Device Publish Date2016-09-24

On-Brand Devices [Anti-Adenovirus IFA (IgM)]

04049016059455FI 2680-2005 M
04049016059448FI 2680-1010 M
04049016059431FI 2680-1005 M
04049016059424FI 2680-1003 M

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