Anti-MPO ELISA (IgG)

GUDID 04049016026761

EUROIMMUN Medizinische Labordiagnostika AG

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016026761
NIH Device Record Keyff434375-aada-4d2a-97c1-44cef3829571
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-MPO ELISA (IgG)
Version Model NumberEA 1211-9601 G
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104049016026761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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