FDA.reportPublic FDA data

IMMAGE

Primary DI
15099590230463
Brand
IMMAGE
Company
Beckman Coulter, Inc.
Model
446470
Catalog number
446470
Device description
IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K964260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964260000IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAGBeckman Instruments, Inc.1997-02-10DFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590230463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023046315099590230463

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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