Anti-Adenovirus ELISA (IgM)

GUDID 04049016028277

EUROIMMUN Medizinische Labordiagnostika AG

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016028277
NIH Device Record Key0450aee0-905f-4f9c-bd72-93a6b5b0f747
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-Adenovirus ELISA (IgM)
Version Model NumberEI 2680-9601 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
GS104049016028277 [Primary]

FDA Product Code

GOAAntisera, Cf, 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 Date2018-08-15
Device Publish Date2016-09-24

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