DEVICE: ALBAsure QC Kit (05060242471353)

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Device Identifier (DI) Information

ALBAsure QC Kit
Z481U

ALBA BIOSCIENCE LTD
05060242471353
GS1
1
Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Red blood cell count IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
KSF Kit, Quality Control For Blood Banking Reagents
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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
No storage/handling found
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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
July 15, 2015

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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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+441314456261
vittorio.borromeo@quotientbd.com
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