N FLC STANDARD SL OPJD05

GUDID 00630414237497

Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on BN Systems.

Siemens Healthcare Diagnostics Products GmbH

Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator Kappa/lambda light chain immunoglobulin IVD, calibrator
Primary Device ID00630414237497
NIH Device Record Keyd6a84d9b-b6c4-4d4f-b4c8-9037a0018640
Commercial Distribution StatusIn Commercial Distribution
Brand NameN FLC STANDARD SL
Version Model Number10873662
Catalog NumberOPJD05
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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414237497 [Primary]
GS100630414246390 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DFHKAPPA, ANTIGEN, ANTISERUM, CONTROL
JIXCalibrator, multi-analyte mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-27
Device Publish Date2018-10-08

On-Brand Devices [N FLC STANDARD SL]

00630414237497Establishment of reference curves for the determination of free light chains (FLC) type kappa an
00842768031441Establishment of reference curves for the determination of free light chains (FLC) type kappa an

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