DEVICE: IH-Card AHG Anti-IgG,-C3d (07611969952151)

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Device Identifier (DI) Information

IH-Card AHG Anti-IgG,-C3d
813411100
813411100
Bio-Rad Medical Diagnostics GmbH
07611969952151
GS1
1
Anti-Human Globulin Anti-IgG, -C3d; Polyspecific; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 48 cards of 6 microtubes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No
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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
Polyspecific antihuman globulin/complement IVD, antibody, agglutination One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, using an agglutination technique.
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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
Special Storage Condition, Specify: Upright position
Storage Environment Temperature: between 18 and 25 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)

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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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