GEENIUS 92465

GUDID 03610520010785

Geenius Reader

BIO-RAD

Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD
Primary Device ID03610520010785
NIH Device Record Keyc835a66a-7d54-4267-bf2b-74aadf10fa3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEENIUS
Version Model Number92465
Catalog Number92465
Company DUNS269902602
Company NameBIO-RAD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com
Phone+1(800)224-6723
EmailTechSupport-Redmond@Bio-Rad.com

Device Dimensions

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Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103610520010785 [Primary]

FDA Product Code

LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

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03610520007877 - PLATELIA2023-08-09 PLATELIA Lyme IgG
03610522220519 - Platelia2023-07-11 Platelia SARS-CoV-2 Total Ab
03610522220526 - Platelia2023-07-11 Platelia SARS-CoV-2 Total Ab
03610520010785 - GEENIUS2023-02-13Geenius Reader
03610520010785 - GEENIUS2023-02-13 Geenius Reader
03610520013328 - EVOLIS2023-02-13 EVOLIS
03610520013571 - PR 41002023-02-13 PR 4100

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