Anti-SARS-CoV-2 ELISA (IgG)

GUDID 04049016145554

EUROIMMUN Medizinische Labordiagnostika AG

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016145554
NIH Device Record Key407124f7-37c0-4e68-9dc1-30b16cc59d88
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-SARS-CoV-2 ELISA (IgG)
Version Model NumberEI 2606-9601 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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]
GS104049016145554 [Primary]

FDA Product Code

QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological
QKOReagent, Coronavirus Serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

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04049016145554 - Anti-SARS-CoV-2 ELISA (IgG)2020-07-30
04049016145554 - Anti-SARS-CoV-2 ELISA (IgG)2020-07-30
04049016109754 - EUROLabLiquidHandler (30-10)2020-02-17
04049016109761 - EUROLabLiquidHandler (30-05)2020-02-17
04049016109778 - EUROLabLiquidHandler (30-08)2020-02-17
04049016109785 - EUROLabLiquidHandler (45-10)2020-02-17
04049016138501 - Anti-PLA2R IFA2019-06-17
04049016072102 - IFA: Granulocyte Mosaic 132019-06-14

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