IFA: Granulocyte Mosaic 2

GUDID 04049016038986

EUROIMMUN Medizinische Labordiagnostika AG

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Primary Device ID04049016038986
NIH Device Record Key7eeeea75-987c-4265-8e0f-f26ac15d4087
Commercial Distribution StatusIn Commercial Distribution
Brand NameIFA: Granulocyte Mosaic 2
Version Model NumberFA 1201-1010-2
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
GS104049016038986 [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 [IFA: Granulocyte Mosaic 2]

04049016071808FA 1201-2010-2
04049016071792FA 1201-2003-2
04049016038993FA 1201-2005-2
04049016038986FA 1201-1010-2
04049016038979FA 1201-1005-2
04049016038962FA 1201-1003-2

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.