FDA.reportPublic FDA data

N FLC SUPPLEMENTARY REAGENT

Primary DI
00630414237473
Brand
N FLC SUPPLEMENTARY REAGENT
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873660
Catalog number
OPJC05
Device description
Immunonephelometric determination of free light chains (FLC) type kappa and type lambda on BN Systems.
Published
2018-10-08
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
DEHLAMBDA, ANTIGEN, ANTISERUM, CONTROL
DFHKAPPA, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEHLambda, Antigen, Antiserum, ControlImmunology2
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
00630414237473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414237473006304142374736304142374730630414237473

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
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414312446N FLC Supplementary ReagentSiemens Healthcare Diagnostics Products GmbHDFH2026-06-26
00630414312446N FLC Supplementary ReagentSiemens Healthcare Diagnostics Products GmbHDEH2026-06-26
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsTHE BINDING SITE GROUP LIMITEDDFH2026-02-02
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
00817089023505DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
00817089023512DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
00817089023512DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
00817089023529DiazymeDIAZYME LABORATORIES, INC.DFH2025-10-22
00817089023529DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
03607360051023FLC KappaSEBIADFH2023-03-31
03607360051030FLC LambdaSEBIADEH2023-03-31
03607360051122FLC Control Level 1SEBIADEH2023-03-31
03607360051122FLC Control Level 1SEBIADFH2023-03-31
03607360051139FLC Control Level 2SEBIADFH2023-03-31
03607360051139FLC Control Level 2SEBIADEH2023-03-31
05051700019866Optilite Freelite Mx Kappa Free KitTHE BINDING SITE GROUP LIMITEDDFH2018-11-16
05051700019873Optilite Freelite Mx Lambda Free KitTHE BINDING SITE GROUP LIMITEDDEH2018-11-16
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbHDFH2018-10-08
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237497N FLC STANDARD SLSiemens Healthcare Diagnostics Products GmbHDFH2018-10-08
00630414237497N FLC STANDARD SLSiemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237503N FLC CONTROL SL2Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
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
00630414167664N LATEX FLC lambdaSiemens Healthcare Diagnostics Products GmbHDEH2018-01-28