N FLC Standard SL OPJD03

GUDID 00842768031441

Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers

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

• Primary Device ID: 00842768031441
• NIH Device Record Key: 7600d7c2-38cd-46eb-89d1-e316abf7498f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N FLC Standard SL
• Version Model Number: 10482440
• Catalog Number: OPJD03
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768031441 [Primary]
GS1	04056869221946 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171742

FDA Product Code

• DFH: KAPPA, ANTIGEN, ANTISERUM, CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-20

On-Brand Devices [N FLC Standard SL]

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