Anti-RSV IFA (IgM)

GUDID 04049016059288

EUROIMMUN Medizinische Labordiagnostika AG

Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016059288
NIH Device Record Keyfde8998e-0fb4-47ad-a564-4134debac7e8
Commercial Distribution Discontinuation2018-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-RSV IFA (IgM)
Version Model NumberFI 2670-1010 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
GS104049016059288 [Primary]

FDA Product Code

LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

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 [Anti-RSV IFA (IgM)]

04049016059295FI 2670-2005 M
04049016059288FI 2670-1010 M
04049016059271FI 2670-1005 M
04049016059264FI 2670-1003 M

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