DEVICE: Solidscreen II Anti-D (RH1) Blend (07611969951512)

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Device Identifier (DI) Information

Solidscreen II Anti-D (RH1) Blend
806530100
806530100
Bio-Rad Medical Diagnostics GmbH
07611969951512
GS1
1
Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Partial (variant) Rh(D) category VI/weak Rh(D) red cell grouping IVD, antibody, solid-phase red blood cell adherence One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for the presence of partial (variant) Rh(D) category VI red blood cell antigens or weak expression of the Rh(D) antigens from the rhesus system, by red blood cells that have been initially screened as Rh (D) negative, 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
No Product Codes
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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
September 17, 2014

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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

[?]
800-224-6723
techsupport.bmd@bio-rad.com
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