EUROLINE Bordetella pertussis (IgA)

GUDID 04049016085430

EUROIMMUN Medizinische Labordiagnostika AG

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016085430
NIH Device Record Key5ec8a07c-aa84-4fcf-93e6-e0ce701c9422
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEUROLINE Bordetella pertussis (IgA)
Version Model NumberDN 2050-1601 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
GS104049016085430 [Primary]

FDA Product Code

GOXAntigen, B. Pertussis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-16
Device Publish Date2016-09-24

On-Brand Devices [EUROLINE Bordetella pertussis (IgA)]

04049016085461DN 2050-24001 A
04049016085430DN 2050-1601 A

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