DEVICE: ALBAcyte B Cells (05060242471148)

Device Identifier (DI) Information

ALBAcyte B Cells
Z411U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471148
GS1

1
516536641 *Terms of Use
2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte B Cells, for tube techniques.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Group B Rh(D) negative reagent red blood cell IVD, antigen A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group B Rh(D) negative. These reagent cells are positive for blood group antigen B [ABO002], and negative for blood group antigen Rh(D) [RH001].
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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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 Record Status

750022ab-f491-4385-a4fe-d85c192fe2a1
March 29, 2018
2
November 14, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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+441314456261
vittorio.borromeo@quotientbd.com
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