IFA: Granulocytes (EOH)

GUDID 04049016071686

EUROIMMUN Medizinische Labordiagnostika AG

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Primary Device ID04049016071686
NIH Device Record Key0c065076-891e-4aca-9064-6ae56ed39524
Commercial Distribution StatusIn Commercial Distribution
Brand NameIFA: Granulocytes (EOH)
Version Model NumberFA 1200-2010
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
GS104049016071686 [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: Granulocytes (EOH)]

04049016103233FA 1200-18010
04049016071686FA 1200-2010
04049016038740FA 1200-2005
04049016038733FA 1200-1010
04049016038726FA 1200-1005
04049016038719FA 1200-1003

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