FDA.reportPublic FDA data

Lambda light chains

Primary DI
08058056681263
Brand
Lambda light chains
Company
SENTINEL CH. SPA
Model
A26849
Catalog number
A26849
Device description
The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems.
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEHLambda, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEHLambda, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083601000LAMBDA LIGHT CHAINSSENTINEL CH. SpA2009-06-22DEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056681263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056681263080580566812638058056681263

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume120Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685308ACE Reagent06U822506U82252025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsTHE BINDING SITE GROUP LIMITEDDEH2026-02-02
00817089023505DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
00817089023512DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
00817089023529DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
03607360051030FLC LambdaSEBIADEH2023-03-31
03607360051122FLC Control Level 1SEBIADEH2023-03-31
03607360051139FLC Control Level 2SEBIADEH2023-03-31
05051700019873Optilite Freelite Mx Lambda Free KitTHE BINDING SITE GROUP LIMITEDDEH2018-11-16
00630414237473N FLC SUPPLEMENTARY REAGENTSiemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237497N FLC STANDARD SLSiemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237503N FLC CONTROL SL2Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414167664N LATEX FLC lambdaSiemens Healthcare Diagnostics Products GmbHDEH2018-01-28
03607360021002CAPILLARYS IMMUNOTYPINGSEBIADEH2018-01-24
03607360023006IT/IF ControlSEBIADEH2018-01-24
03607360026007CAPI 3 IMMUNOTYPINGSEBIADEH2018-01-24
05051700019675Optilite Freelite Lambda Free Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2017-04-25
B1761180antiserum to Human Lambda (free and bound)KENT LABORATORIES INCDEH2016-09-24
05051700006286Freelite® Human Kappa Free Kit for use on the Beckman AU® series THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006392Freelite® Human Lambda Free Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006408Freelite® Human Lambda Free Kit for use on the Beckman AU® series THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006415Freelite® Human Lambda Free Kit for use on the ADVIA® THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006439Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006446Freelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006460Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra® THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006477Freelite® Human Lambda Free Kit for use on the SPAPLUS THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006491Freelite® Human Lambda Free Kit for use on the Siemens BN™II THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700010177Sheep Anti-Human Lambda Free Light Chains Immunofixation GradeTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700012102Freelite® Human Lambda Free Kit for use on the Roche cobas® c systemsTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700012201Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2016-09-24