N Latex IgA OQAI11

GUDID 00842768007200

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

Siemens Healthcare Diagnostics Products GmbH

Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00842768007200
• NIH Device Record Key: 5c1a02ca-569e-45a2-93ee-a4cfef49b268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N Latex IgA
• Version Model Number: 10446036
• Catalog Number: OQAI11
• 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: 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	00842768007200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024038

FDA Product Code

• CZP: IGA, 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: 2016-09-24

On-Brand Devices [N Latex IgA]

• 00842768007200: Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
• 00630414285030: Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems