DEVICE: Solidscreen II Strip (07611969951499)
Device Identifier (DI) Information
Solidscreen II Strip
806521100
In Commercial Distribution
806521100
Bio-Rad Medical Diagnostics GmbH
806521100
In Commercial Distribution
806521100
Bio-Rad Medical Diagnostics GmbH
Microplate for use in detection of red blood cell antibodies and antigens in indirect and direct antiglobulin tests with solid phase antiglobulin technique on TANGO instruments; 10 plates
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
58814 | Solid-phase red blood cell adherence antibody/antigen IVD |
A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid-phase red blood cell adherence method.
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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 [?] |
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BK040070 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0e869601-a3f5-4b17-9f0f-8bf5949f0792
July 08, 2021
4
July 01, 2015
July 08, 2021
4
July 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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