FDA.report

Sheep Anti-Human Kappa Free Light Chains Immunofix

Primary DI
05051700010146
Brand
Sheep Anti-Human Kappa Free Light Chains Immunofix
Company
THE BINDING SITE GROUP LIMITED
Model
PX016
Published
2016-09-24
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
DFHKappa, Antigen, Antiserum, Control

Product Code Classifications

CodeDeviceSpecialtyClass
DFHKappa, Antigen, Antiserum, ControlImmunology2

Premarket Submissions

SubmissionSupplement
K002564000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K002564000SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.2000-10-26DFH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700010146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700010146050517000101465051700010146

GMDN Terms

TermDefinition
Kappa/lambda light chain immunoglobulin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection 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
false
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

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
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsTHE BINDING SITE GROUP LIMITEDDFH2026-02-02
03607360051023FLC KappaSEBIADFH2023-03-31
03607360051122FLC Control Level 1SEBIADFH2023-03-31
03607360051139FLC Control Level 2SEBIADFH2023-03-31
05051700019866Optilite Freelite Mx Kappa Free KitTHE BINDING SITE GROUP LIMITEDDFH2018-11-16
00630414237473N FLC SUPPLEMENTARY REAGENTSiemens Healthcare Diagnostics Products GmbHDFH2018-10-08
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbHDFH2018-10-08
00630414237497N FLC STANDARD SLSiemens Healthcare Diagnostics Products GmbHDFH2018-10-08
00842768031434N FLC Supplementary ReagentSiemens Healthcare Diagnostics Products GmbHDFH2018-02-20
00842768031441N FLC Standard SLSiemens Healthcare Diagnostics Products GmbHDFH2018-02-20
00842768031458N FLC Control SL1Siemens Healthcare Diagnostics Products GmbHDFH2018-02-20
00842768031465N FLC Control SL2Siemens Healthcare Diagnostics Products GmbHDFH2018-02-20
00630414167657N LATEX FLC KAPPASiemens Healthcare Diagnostics Products GmbHDFH2018-01-28
05051700019651Optilite Freelite Kappa Free Bulk KitTHE BINDING SITE GROUP LIMITEDDFH2017-04-25
B1761170Antiserum to Human Kappa (free and bound)KENT LABORATORIES INCDFH2016-09-24
05051700006279Freelite® Human Kappa Free Kit for use on the SiemTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006293Freelite® Human Kappa Free Kit for use on the SiemTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006316Freelite® Human Kappa Free Kit for use on the HITATHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006323Freelite® Human Kappa Free Kit for use on the BeckTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006347Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® THE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006354Freelite® Human Kappa Free Kit for use on the SPAPTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006378Freelite® Human Kappa Free Kit for use on the SiemTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700012096Freelite® Human Kappa Free Kit for use on the RochTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700012188Freelite® Human Kappa Free Kit for use on the SPAPTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700012355Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® - Bulk kitTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700016063Freelite® Human Kappa Free Kit for use on the RochTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700017794Optilite Freelite Kappa KitTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
00842768006357DImension Vista® Protein 1 Control H (high)Siemens Healthcare Diagnostics Products GmbHDFH2016-09-24
00842768012686N Antiserum to Human-Ig/L-chain, K-typeSiemens Healthcare Diagnostics Products GmbHDFH2016-09-24
00842768012709N Antiserum to Human-Ig/L-chain, L-typeSiemens Healthcare Diagnostics Products GmbHDFH2016-09-24