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

• Primary Device ID: 00630414167657
• NIH Device Record Key: b2c1a2ac-43b1-49b0-9a9b-5830bd6338c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N LATEX FLC KAPPA
• Version Model Number: 10873629
• Catalog Number: OPJA075
• 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: 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
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• 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
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• Phone: +1(800)664-3822
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• 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
• 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
• 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	00630414167657 [Primary]
GS1	00630414229072 [Unit of Use]

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: 5
• Public Version Date: 2019-05-20
• Device Publish Date: 2018-01-28

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