DEVICE: Solidscreen II Strip (07611969951499)

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Device Identifier (DI) Information

Solidscreen II Strip
806521100
806521100
Bio-Rad Medical Diagnostics GmbH
07611969951499
GS1
1
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
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
KSZ System, Test, Automated Blood Grouping And Antibody
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
July 01, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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800-224-6723
techsupport.bmd@bio-rad.com
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