DEVICE: ALBAcyte IgG Sensitized Red Blood Cells (05060242471162)
Device Identifier (DI) Information
ALBAcyte IgG Sensitized Red Blood Cells
Z441U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
52716 | Immunoglobulin-sensitized reagent red blood cell IVD, control |
A sample of reagent red blood cells sensitized to or coated with antibodies [e.g., immunoglobulin G (IgG) or immunoglobulin M (IgM)] intended to be used to verify the performance of an assay (e.g., Coombs control) for evaluation of a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSF | Kit, Quality Control For Blood Banking Reagents |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK100005 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f84e269f-8983-4a82-9de8-79546292c5fb
April 02, 2025
8
September 24, 2016
April 02, 2025
8
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441313573333
Victoria.Vanhoutte@alivedx.com
Victoria.Vanhoutte@alivedx.com