Anti-Candida albicans IFA (IgM)

GUDID 04049016067863

EUROIMMUN Medizinische Labordiagnostika AG

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016067863
NIH Device Record Keya9a5d378-146d-40f3-92c4-8cde9859e551
Commercial Distribution Discontinuation2018-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-Candida albicans IFA (IgM)
Version Model NumberFI 2861-1005 M
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
GS104049016067863 [Primary]

FDA Product Code

LSGCandida Species, Antibody Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-14
Device Publish Date2016-10-10

On-Brand Devices [Anti-Candida albicans IFA (IgM)]

04049016067887FI 2861-2005 M
04049016067870FI 2861-1010 M
04049016067863FI 2861-1005 M
04049016067856FI 2861-1003 M

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