FDA.reportPublic FDA data

LISS

Primary DI
23661562105445
Brand
LISS
Company
DIAGAST
Model
210544
Catalog number
210544
Device description
Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohematological testing in tube methods
Published
2018-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
23661562105445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366156210544523661562105445

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 by reducing the zeta potential of red blood cells. 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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 452-6877service.americas@grifols.com

Regulatory Flags#

DUNS number
381527001
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
23661562173192Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63)17319173192015-09-04
23661562173178Beckman Coulter® PK® Systems Control17317173172016-01-12
23661562173307Beckman Coulter® PK® Systems Bromelin17330173302015-09-18
23661562105469Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green2105462105462018-05-01
23661562105476Anti-Human Globulin Anti-IgG - Green2105472105472018-05-01
23661562105490Anti-Human Globulin Anti-IgG - Clear2105492105492018-05-01
23661562105506Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear2105502105502018-05-01
23661562495584Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)B49558B495582020-10-20
23661562105209Anti-A (AB01)2105202105202018-05-01
23661562105216Anti-B (AB02)2105212105212018-05-01
23661562105223Anti-A,B (AB03)2105222105222018-05-01
23661562105247Anti-D (RH1) IgG2105242105242018-05-01
23661562105254Anti-D (RH1) IgM2105252105252018-05-01
23661562105278Anti-C (RH2)2105272105272018-05-01
23661562105285Anti-c (RH4)2105282105282018-05-01
23661562105292Anti-E (RH3)2105292105292018-05-01
23661562105308Anti-e (RH5)2105302102302018-05-01
23661562105315Anti-Fya (FY1)2105312105312018-05-01
23661562105322Anti-Fyb (FY2)2105322105322018-05-01
23661562105339Anti-K (KEL1)2105332105332018-05-01

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
00858400005121LISSAmerican National Red CrossKSG2018-09-17
10858400005104PEGAMERICAN NATIONAL RED CROSSKSG2018-09-17
10858400005128LISSAMERICAN NATIONAL RED CROSSKSG2018-09-17
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