N LATEX FLC KAPPA OPJA075

GUDID 00630414167657

Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers

Siemens Healthcare Diagnostics Products GmbH

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Primary Device ID00630414167657
NIH Device Record Keyb2c1a2ac-43b1-49b0-9a9b-5830bd6338c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameN LATEX FLC KAPPA
Version Model Number10873629
Catalog NumberOPJA075
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414167657 [Primary]
GS100630414229072 [Unit of Use]

FDA Product Code

DFHKAPPA, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-20
Device Publish Date2018-01-28

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

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00842768018886 - Coagulation Factor V Deficient Plasma2024-02-27 For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
00842768006661 - vWF Ag2023-06-26 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
00842768028014 - INNOVANCE VWF Ac2022-10-18 In-vitro diagnostic automated assay for the quantitative determination of the von Willebrandfactor-GPIb-binding activity in huma
00630414287430 - N LP(a) Standard SY2020-10-20 Calibration of Lp(a) assay on BN Systems
00630414287416 - N/T Rheumatology Control SL/12020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems
00630414287423 - N/T Rheumatology Control SL/22020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems

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