Anti-RSV ELISA (IgA)

GUDID 04049016028222

EUROIMMUN Medizinische Labordiagnostika AG

Respiratory syncytial virus (RSV) immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016028222
NIH Device Record Keyda643ac9-9898-4a34-a359-c3b1852bde4d
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnti-RSV ELISA (IgA)
Version Model NumberEI 2670-9601 A
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
GS104049016028222 [Primary]

FDA Product Code

MCERespiratory Syncytial Virus - Elisa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-15
Device Publish Date2016-09-24

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