FDA.reportPublic FDA data

FLC Kappa

Primary DI
03607360051023
Brand
FLC Kappa
Company
SEBIA
Model
5102
Catalog number
5102
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210623000FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia2022-11-18DFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607360051023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607360051023036073600510233607360051023

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This way up Do Not Freeze Fragile-Handle with Care Keep Dry
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276801933
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
03607360043165ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK)431643162026-01-09
03607360043189ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK)431843182026-01-09
03607360043875HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438743872026-01-09
03607360048160ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK)481648162026-01-09
03607360048177ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK)481748172026-01-09
03607360048184ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK)481848182026-01-09
03607360048191ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)481948192026-01-09
03607360043196ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK)431943192026-01-08
03607360043868HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438643862026-01-08
03607360043882HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438843882026-01-08
03607360043899HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)438943892026-01-08
03607360048863HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488648862026-01-08
03607360048870HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488748872026-01-08
03607360048887HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488848882026-01-08
03607360048894HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)488948892026-01-08
03607360012444CAPILLARYS 3 DBS124412442024-04-30
03607360025062CAPI 3 NEONAT Hb250625062024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTION256325632024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATES257825782024-04-30
03607360047576CAPI 3 NEONAT Hb AF Control475747572024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsTHE BINDING SITE GROUP LIMITEDDFH2026-02-02
00817089023505DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
00817089023512DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
00817089023529DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
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
00630414237503N FLC CONTROL SL2Siemens 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
03607360021002CAPILLARYS IMMUNOTYPINGSEBIADFH2018-01-24
03607360023006IT/IF ControlSEBIADFH2018-01-24
03607360026007CAPI 3 IMMUNOTYPINGSEBIADFH2018-01-24
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 Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006293Freelite® Human Kappa Free Kit for use on the Siemens ADVIA® THE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006316Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P THE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006323Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800THE 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 SPAPLUS THE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700006378Freelite® Human Kappa Free Kit for use on the Siemens BN™IITHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700010146Sheep Anti-Human Kappa Free Light Chains Immunofixation GradeTHE BINDING SITE GROUP LIMITEDDFH2016-09-24
05051700012096Freelite® Human Kappa Free Kit for use on the Roche cobas® systems THE BINDING SITE GROUP LIMITEDDFH2016-09-24