DEVICE: DOCTOR'S KIT DKS RhD-25 (05713494000351)

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Device Identifier (DI) Information

DOCTOR'S KIT DKS RhD-25
669-00v07
669-00
Eldon Biologicals A/S
05713494000351
GS1
75
For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for 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
Anti-Rh(D) red blood cell grouping IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, 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
Handling Environment Temperature: between 5 and 37 Degrees Celsius
Storage 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
December 13, 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: 05713494000320 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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