ADVIA Centaur® Active B12 10995090

GUDID 00630414603117

Active B12 - CENTAUR - MCM

Siemens Healthcare Diagnostics Inc.

Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control Holotranscobalamin (holoTC) IVD, control

• Primary Device ID: 00630414603117
• NIH Device Record Key: 66caecc4-3030-4a64-ae25-df2c2036ffc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur® Active B12
• Version Model Number: 10995090
• Catalog Number: 10995090
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• 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: true
• 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(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414603117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160757

FDA Product Code

• JJX: SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [ADVIA Centaur® Active B12]

• 00630414603100: Active B12 - RGT - CENTAUR - 100T
• 00630414603117: Active B12 - CENTAUR - MCM