TANGO optimo 848900010

GUDID 07611969961696

Instrument

Bio-Rad Medical Diagnostics GmbH

Immunohaematology/blood bank analyser IVD, automated Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD
Primary Device ID07611969961696
NIH Device Record Keya5308f60-0b01-466e-b938-843c66d593fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameTANGO optimo
Version Model Number848900010
Catalog Number848900010
Company DUNS312576506
Company NameBio-Rad Medical Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107611969961696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

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 Date2016-08-15

Devices Manufactured by Bio-Rad Medical Diagnostics GmbH

03610520569870 - IH-Com2022-03-22 IH-Com Kit Fullversion US; Software Version: 04.0.27.
03610522055685 - IH-Card ABO Neutral2022-03-17 The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
07611969964505 - IH-Titration Rack2022-03-17 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.
07611969952205 - IH-Titration Solution2022-03-11 IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with a
07611969233786 - IH-5002022-01-31 IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of hu
03610522123919 - IH-Com V5.22021-02-26 IH-Com V5.2, Software Version 5.2
03610522165049 - Wash Solution A Concentrate2020-02-13 Wash Solution for use with the IH-500
07611969951369 - Alsevers Solution2019-11-27 Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods

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