FDA.reportPublic FDA data

N FLC Supplementary Reagent

Primary DI
00842768031434
Brand
N FLC Supplementary Reagent
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10482439
Catalog number
OPJC03
Device description
Quantitative determination of free light chains (FLC) type kappa and type lambda in human serum and EDTA-plasma on Siemens analyzers
Published
2018-02-20
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171742000N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH2017-11-17DFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768031434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768031434008427680314348427680314340842768031434

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.

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
1
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
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