FDA.reportPublic FDA data

N LATEX FLC KAPPA

Primary DI
00630414167657
Brand
N LATEX FLC KAPPA
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873629
Catalog number
OPJA075
Device description
Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers
Published
2018-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DFHKAPPA, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414167657PrimaryGS10
00630414229072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414167657006304141676576304141676570630414167657
00630414229072006304142290726304142290720630414229072

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)664-3822XX@XX.XX
+1(800)664-3822CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

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
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
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
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