DEVICE: Biotestcell® 1 & 2 (07611969952380)

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Device Identifier (DI) Information

Biotestcell® 1 & 2
816014100
816014100
Bio-Rad Medical Diagnostics GmbH
07611969952380
GS1
1
Reagent Red Blood Cells; 3.0 - 3.4%; for use in detection of unexpected antibodies with TANGO instruments and by tube test; 2x10ml
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Antibody screening reagent red blood cell IVD, kit, agglutination A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination 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

[?]
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)

[?]
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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