N FLC SUPPLEMENTARY REAGENT OPJC05

GUDID 00630414237473

Immunonephelometric 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, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent Kappa/lambda light chain immunoglobulin IVD, reagent

• Primary Device ID: 00630414237473
• NIH Device Record Key: 729b6166-9d6d-46a8-b9a2-79d3f315b8c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N FLC SUPPLEMENTARY REAGENT
• Version Model Number: 10873660
• Catalog Number: OPJC05
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 1
• 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: false
• 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: 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414237473 [Primary]

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: 2
• Public Version Date: 2019-05-27
• Device Publish Date: 2018-10-08

On-Brand Devices [N FLC SUPPLEMENTARY REAGENT]

• 00630414237473: Immunonephelometric determination of free light chains (FLC) type kappa and type lambda on BN Sy
• 00842768031434: Quantitative determination of free light chains (FLC) type kappa and type lambda in human serum