FDA.report

Freelite Kappa Free Panel Sample Set

Primary DI
05051700020169
Brand
Freelite Kappa Free Panel Sample Set
Company
THE BINDING SITE GROUP LIMITED
Model
BP233
Published
2017-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700020169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700020169050517000201695051700020169

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4401214569500info@bindingsite.co.uk

Regulatory Flags

DUNS number
347045614
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control PackMSQ801.M2025-11-27
05051700020640EXENT® Diluent 1IK8762025-11-27
05051700020657EXENT® Elution buffer 1 IK8772025-11-27
05051700020664EXENT® HCCA MALDI Matrix PackIK8202025-11-27
05051700020671EXENT® Mass calibration standard 1 MSS801.M2025-11-27
05051700020688EXENT® Disposable MALDI plate pack IK8192025-11-27
05051700020695EXENT® Wash solution 1 IK8222025-11-27
05051700020886EXENT® AnalyserIE800.A2025-11-27
05051700021050Immunoglobulin Isotypes (GAM) for the EXENT AnalyserMSR801.M.A2025-11-27
05051700021098Optilite® CH50 ReagentNK095.OPT.A2024-11-20
05051700019392Optilite® Low Level Total Protein ControlsNQ061.L.OPT2024-10-30
05051700020534Optilite® Low Level Total Protein CalibratorNC061.L.OPT2024-10-30
05051700020558Optilite® Low Level Total Protein ReagentNK061.L.OPT.A2024-10-30
05051700021036Optilite® IgG3 Kit (x10)LK008.10.OPT.A2023-09-27
05051700021043Optilite® IgG4 Kit (x10)LK009.10.OPT.A2023-09-27
05051700016803Freelite® Kappa AMR Check Fluid SDBP538.SD2023-08-09
05051700016810Freelite® Lambda AMR Check Fluid SDBP539.SD2023-08-09
05051700002059Freelite® Panel Sample SetBP2282023-06-29

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