DEVICE: ALBAhance PEG (05060242471537)

Device Identifier (DI) Information

ALBAhance PEG
Z312U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471537
GS1

1
516536641 *Terms of Use
ALBAhance PEG for the potentiation of indirect antiglobulin tests.
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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
Polyethylene glycol (PEG) immunohaematology reagent IVD A substance or reactant that is a polyethylene glycol (PEG) solution, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate agglutination reactions by reducing the zeta potential of red blood cells.
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FDA Product Code

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Product Code Product Code Name
KSG Media, Potentiating For In Vitro Diagnostic Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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

0f1bc271-8f7d-456e-bc5d-9169fe8ef9c9
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
05060242471100 10 05060242471537 In Commercial Distribution Carton
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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