DEVICE: ALBAcyte IgG Sensitized Red Blood Cells (05060242471162)

Device Identifier (DI) Information

ALBAcyte IgG Sensitized Red Blood Cells
Z441U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471162
GS1

1
516536641 *Terms of Use
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
No
No
No
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
Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control A sample of specifically characterized reagent red blood cells intended to be used when testing a clinical specimen, due to their sensitization or cell coating with immunoglobulin G (IgG) antibodies, to verify the performance of an assay.
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK100005 0
No CLOSE

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 Record Status

f84e269f-8983-4a82-9de8-79546292c5fb
July 06, 2018
3
September 24, 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

[?]
+441314456261
vittorio.borromeo@quotientbd.com
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