DEVICE: ALBAsera Anti-Fyb (05060242470981)

Device Identifier (DI) Information

ALBAsera Anti-Fyb
Z153U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242470981
GS1

1
516536641 *Terms of Use
Blood Grouping Reagent, ALBAsera Anti-Fyb (Polyclonal) for indirect antiglobulin test by tube technique.
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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
Anti-Fy^b red blood cell grouping IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Fy^b [FY002] red blood cell antigens from the Duffy system, using an agglutination method.
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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
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

e9167384-92df-4b37-9c16-a615a6b4a857
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
No
Yes
No
No CLOSE

Customer Contact

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+441314456261
vittorio.borromeo@quotientbd.com
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