FDA.reportPublic FDA data

Freelite® Lambda AMR Check Fluid SD

Primary DI
05051700016810
Brand
Freelite® Lambda AMR Check Fluid SD
Company
THE BINDING SITE GROUP LIMITED
Model
BP539.SD
Published
2023-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700016810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700016810050517000168105051700016810

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.

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
+441214569500info@bindingsite.co.uk

Regulatory Flags#

DUNS number
347045614
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsLK016.CB.A2026-02-02
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsLK018.CB.A2026-02-02
05051700006316Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P LK016.H2016-09-24
05051700006323Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800LK016.IM2016-09-24
05051700006439Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P LK018.H2016-09-24
05051700010269Total Haemolytic Complement RC001.12016-09-24
05051700010276Total Haemolytic Complement RC001.22016-09-24
05051700010283Total Haemolytic Complement RC001.32016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitRK0212016-09-24
05051700010504Human C1 Inactivator BINDARID™ Radial Immunodiffusion KitRN019.32016-09-24
05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitRN025.32016-09-24
05051700010764Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion KitRN065.32016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsRN106.32016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsRN107.32016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsRN108.32016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsRN109.32016-09-24
05051700016919Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II NK623.T.A2016-09-24
05051700016926Hevylite IgA Lambda Kit for Siemens BNIINK624.T.A2016-09-24
05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™NQ018.IM2017-06-05
05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/NQ016.IM2017-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23