DEVICE: IH-Cell Pool (07611969952281)

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Device Identifier (DI) Information

IH-Cell Pool
814060100
814060100
Bio-Rad Medical Diagnostics GmbH
07611969952281
GS1
1
Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for use in detection of unexpected antibodies with IH-Cards; 1 x 10 mL
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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
Pooled antibody screening reagent red blood cell IVD, antigen A collection of two or three specifically characterized reagent red blood cells pooled together into a single sample, and intended to be used in screening a clinical specimen to detect antibodies to red blood cell antigens.
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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

[?]
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
January 20, 2017

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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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