DEVICE: Gamma LO-ION (10888234001775)
Device Identifier (DI) Information
Gamma LO-ION
0704610
In Commercial Distribution
0704610
IMMUCOR, INC.
0704610
In Commercial Distribution
0704610
IMMUCOR, INC.
Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
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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52718 | 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. It is a solution typically consisting of a sodium salt, glycine and low-salt albumin.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KSG | Media, Potentiating For In Vitro Diagnostic Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K790973 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 1 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9420f8f8-c276-42d7-abf2-2df4fed98c1b
July 07, 2020
5
April 15, 2016
July 07, 2020
5
April 15, 2016
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
[?]
1-855-466-8267
tech_support@immucor.com
tech_support@immucor.com