Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)

GUDID 04049016126003

EUROIMMUN Medizinische Labordiagnostika AG

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016126003
NIH Device Record Keya589cf7a-2162-4be8-806c-8599c794d4c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Borrelia burgdorferi US WESTERNBLOT (IgG)
Version Model NumberDY 2133-3001 G
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104049016126003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSRReagent, Borrelia Serological Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)]

04049016126010DY 2133-24001 G
04049016126003DY 2133-3001 G

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