FDA.reportPublic FDA data

LISS

Primary DI
00858400005121
Brand
LISS
Company
American National Red Cross
Model
510177
Device description
LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from glycine and albumin.
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSGMedia, Potentiating For In Vitro Diagnostic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSGMedia, Potentiating For In Vitro Diagnostic UseHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858400005128PackageGS15In Commercial Distribution
00858400005121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085840000512810858400005128
00858400005121008584000051218584000051210858400005121

GMDN Terms#

Term, Definition table
TermDefinition
Low ionic-strength salt solution (LISS) immunohaematology reagent IVDA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
003255213
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858400005138Anti-C (Human/Murine Monoclonal)5101462026-03-06
00858400005145Anti-c (Human/Murine Monoclonal)5101472026-03-06
00858400005152Anti-S (Human/Murine Monoclonal)5101532026-03-06
00858400005169Anti-s (Human/Murine Monoclonal)5101542026-03-06
00858400005176Anti-k (Human/Murine Monoclonal)(IgG)5101492026-03-06
00858400005183Anti-E (Human/Murine Monoclonal)5101482026-03-06
00858400005190Anti-Jka (Human/Murine Monoclonal)5101512026-03-06
00858400005206Anti-Jkb (Human/Murine Monoclonal)5101522026-03-06
00858400005091Control Cells510400/5104022016-07-21
00858400005107PEG5101792018-09-17
00858400005114Red Cell Storage Solution5102652020-07-17
00858400005008Anti-K5102002014-09-12
00858400005015Anti-k5102022014-11-04
00858400005022Anti-Kpa5102042014-09-12
00858400005039Anti-Kpb5102052014-09-12
00858400005046Anti-M5102062014-09-12
00858400005053Anti-S5102222014-09-12
00858400005060Anti-s5102242014-09-12
00858400005077Anti-Fya5102152014-09-12
00858400005084DailyChek QC Kit5103952016-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSG2023-10-13
07611969964505IH-Titration RackBio-Rad Medical Diagnostics GmbHKSG2022-03-09
07611969952205IH-Titration SolutionBio-Rad Medical Diagnostics GmbHKSG2022-03-03
00858400005107PEGAmerican National Red CrossKSG2018-09-17
10858400005104PEGAMERICAN NATIONAL RED CROSSKSG2018-09-17
10858400005128LISSAMERICAN NATIONAL RED CROSSKSG2018-09-17
23661562105445LISSDIAGASTKSG2018-05-01
07611969952182IH-LISS SolutionBio-Rad Medical Diagnostics GmbHKSG2018-04-05
07611969069934IH-LISS RackBio-Rad Medical Diagnostics GmbHKSG2017-01-20
00858352006023ELUclear HEMO BIOSCIENCE INCKSG2016-09-27
10758750006038MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750006045MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750007820ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10758750007837ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10888234000167ImmuAddIMMUCOR, INC.KSG2016-04-15
10888234000235Bovine Albumin Solution 22%IMMUCOR, INC.KSG2016-04-15
10888234001775Gamma LO-IONIMMUCOR, INC.KSG2016-04-15
10888234001782Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001799Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001805Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234001812Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234000860Gamma ELU-KIT IIIMMUCOR, INC.KSG2016-04-14
10888234000877Gamma EGA KitIMMUCOR, INC.KSG2016-04-14
05060242471520Bovine Serum Albumin 22%ALBA BIOSCIENCE LIMITEDKSG2014-11-14
05060242471537ALBAhance PEGALBA BIOSCIENCE LIMITEDKSG2014-11-14