N Latex IgM OQAC15

GUDID 00630414285023

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems

Siemens Healthcare Diagnostics Products GmbH

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00630414285023
• NIH Device Record Key: 43d63b13-be99-4020-8a0f-606760439877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N Latex IgM
• Version Model Number: 10873688
• Catalog Number: OQAC15
• 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
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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
• 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
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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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414285023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032014

FDA Product Code

• CFN: METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-29

On-Brand Devices [N Latex IgM]

• 00842768007194: Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
• 00630414285023: Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems