DEVICE: TANGO optimo (07611969961696)
Device Identifier (DI) Information
TANGO optimo
848900010
In Commercial Distribution
848900010
Bio-Rad Medical Diagnostics GmbH
848900010
In Commercial Distribution
848900010
Bio-Rad Medical Diagnostics GmbH
Instrument
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57846 | Immunohaematology/blood bank analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening/identification/titration, direct antiglobulin tests and/or crossmatching of clinical specimens (from donor and patient). It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSZ | System, Test, Automated Blood Grouping And Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK080013 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a5308f60-0b01-466e-b938-843c66d593fe
September 16, 2022
4
August 15, 2016
September 16, 2022
4
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-224-6723
techsupport.bmd@bio-rad.com
techsupport.bmd@bio-rad.com