IFA: Legionella pneumophila Screening (Mix 1 / Mix

GUDID 04049016053330

EUROIMMUN Medizinische Labordiagnostika AG

Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016053330
NIH Device Record Keyd8be1c3b-8f2c-4c36-bd46-de1952db857f
Commercial Distribution Discontinuation2018-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIFA: Legionella pneumophila Screening (Mix 1 / Mix
Version Model NumberFI 215b-2005-1 P
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
GS104049016053330 [Primary]

FDA Product Code

LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

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 Date2016-09-24

On-Brand Devices [IFA: Legionella pneumophila Screening (Mix 1 / Mix]

04049016077848FI 215b-2010-1 P
04049016053330FI 215b-2005-1 P
04049016053323FI 215b-1010-1 P
04049016053316FI 215b-1005-1 P
04049016053309FI 215b-1003-1 P

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