DEVICE: ELDON HOME KIT HKA 2511-1 (05713494000030)

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Device Identifier (DI) Information

ELDON HOME KIT HKA 2511-1
500-07v08
500-07
Eldon Biologicals A/S
05713494000030
GS1
1
For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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
ABO/Rh(D) multiple blood grouping IVD, kit, agglutination A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of one or multiple ABO system and/or Rh (D) (RH001) red blood cell antigens, using an agglutination method.
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FDA Product Code

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Product Code Product Code Name
KSZ System, Test, Automated Blood Grouping And Antibody
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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 5 and 37 Degrees Celsius
Handling Environment Temperature: between 5 and 37 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 07, 2016

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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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+4545931111
eldoncard@eldoncard.com
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