DEVICE: Coombscell-E (07611969952502)

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Device Identifier (DI) Information

Coombscell-E
816030100
816030100
Bio-Rad Medical Diagnostics GmbH
07611969952502
GS1
1
IgG-coated red blood cells for the control of antiglobulin test; 10ml
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
No
No
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
Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control A sample of specifically characterized reagent red blood cells intended to be used when testing a clinical specimen, due to their sensitization or cell coating with immunoglobulin G (IgG) antibodies, to verify the performance of an assay.
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FDA Product Code

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Product Code Product Code Name
KSF Kit, Quality Control For Blood Banking Reagents
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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