DEVICE: ALBAhance LISS Additive Reagent (05060242471544)

Device Identifier (DI) Information

ALBAhance LISS Additive Reagent
Z333U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471544
GS1

1
516536641 *Terms of Use
ALBAhance LISS Additive Reagent.
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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
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD A substance or reactant known as low ionic-strength salt solution (LISS), or low ionic strength saline, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells. It is a solution typically consisting of a sodium salt, glycine and low-salt albumin.
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FDA Product Code

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Product Code Product Code Name
KSK Solution, Stabilized Enzyme
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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

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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

40b4435b-df5e-42a4-808c-68b2f48c80ef
September 12, 2018
3
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
05060242471117 10 05060242471544 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)

[?]
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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