N Antiserum to Human Apolipoprotein B OSAN15

GUDID 00842768009686

Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems

Siemens Healthcare Diagnostics Products GmbH

Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00842768009686
• NIH Device Record Key: e14a5138-7cb2-4202-bf4b-379db4ef7668
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N Antiserum to Human Apolipoprotein B
• Version Model Number: 10446287
• Catalog Number: OSAN15
• 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	00842768009686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860894

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: 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 Antiserum to Human Apolipoprotein B]

• 00842768009686: Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
• 00842768009679: Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems