Anti-Brucella abortus ELISA (IgA)

GUDID 04049016027553

EUROIMMUN Medizinische Labordiagnostika AG

Multiple Brucella species immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016027553
NIH Device Record Key271d5095-cc72-40e2-b6dc-987d74e07f39
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-Brucella abortus ELISA (IgA)
Version Model NumberEI 2189-9601 A
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
GS104049016027553 [Primary]

FDA Product Code

GSMAntisera, Fluorescent, Brucella Spp.

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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