EUROPLUS Granulocyte Mosaic 32

GUDID 04049016091264

EUROIMMUN Medizinische Labordiagnostika AG

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Primary Device ID04049016091264
NIH Device Record Keybb6b0247-e81b-4410-a454-64e95bf72290
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUROPLUS Granulocyte Mosaic 32
Version Model NumberFA 1201-1010-32
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
GS104049016091264 [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

On-Brand Devices [EUROPLUS Granulocyte Mosaic 32]

04049016091288FA 1201-2010-32
04049016091271FA 1201-2005-32
04049016091264FA 1201-1010-32
04049016091257FA 1201-1005-32
04049016091240FA 1201-1003-32
04049016159704FA 1201-12010-32

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