DEVICE: ALBAcyte Orr cells (05060242471155)
Device Identifier (DI) Information
ALBAcyte Orr cells
Z421U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Z421U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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52684 | Group O 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 O Rh (D) negative. These reagent cells are negative for blood group antigens A [ABO001], B [ABO002] and AB [ABO003], and negative for blood group antigen Rh (D) [RH001].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
2f55c14d-e792-4734-8101-92958fae087c
March 31, 2022
4
January 08, 2015
March 31, 2022
4
January 08, 2015
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
[?]
+41225458274
olivia.baud@quotientbd.com
olivia.baud@quotientbd.com