DEVICE: ALBAcyte Antibody Identification (16-Cell) (05060242471384)
Device Identifier (DI) Information
ALBAcyte Antibody Identification (16-Cell)
Z473U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Z473U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Reagent Red Blood Cells, ALBAcyte Antibody Identification (16-Cell) for tube techniques, 2-3% suspension.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
No | |
No | |
No | |
Yes | |
No | |
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? |
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52543 | Antibody identification panel reagent red blood cell IVD, kit, agglutination |
A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.
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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
d35846de-0d38-4e6d-8539-361f69dc06f5
March 31, 2022
4
November 15, 2014
March 31, 2022
4
November 15, 2014
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