ADVIA Centaur aTPOII Diluent 11207635

GUDID 00630414609409

aTPOII ADVIA Centaur - Diluent 2 x 5.0 mL

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Buffered sample diluent IVD

• Primary Device ID: 00630414609409
• NIH Device Record Key: a9e0afb1-2e2d-4e79-8cae-f5eb39365313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur aTPOII Diluent
• Version Model Number: 11207635
• Catalog Number: 11207635
• Company DUNS: 296822794
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• 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(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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414609409 [Primary]

FDA Product Code

• JZO: SYSTEM, TEST, THYROID AUTOANTIBODY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-08
• Device Publish Date: 2025-11-21

Devices Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

• 00630414245317 - Atellica IM Anti-Thyroglobulin II (aTgII): 2026-02-12 Atellica IM Anti-Thyroglobulin II (aTgII) - 100T
• 00630414245324 - Atellica IM Anti-Thyroglobulin II (aTgII): 2026-02-12 Atellica IM Anti-Thyroglobulin II (aTgII) - 500T
• 00630414245331 - Atellica IM aTgII Quality Control (aTgII QC): 2026-02-12 Atellica IM aTgII Quality Control Material
• 00630414245348 - Atellica IM aTgII Master Curve Material (aTgII MCM): 2026-02-12 Atellica IM aTgII Master Curve Material
• 00630414245355 - ADVIA Centaur Anti-Thyroglobulin II (aTgII): 2026-02-12 ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 100T
• 00630414245362 - ADVIA Centaur Anti-Thyroglobulin II (aTgII): 2026-02-12 ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 500T
• 00630414245379 - ADVIA Centaur aTgII Quality Control (aTgII QC): 2026-02-12 ADVIA Centaur aTgII Quality Control Material
• 00630414245386 - ADVIA Centaur aTgII Master Curve Material (aTgII MCM): 2026-02-12 ADVIA Centaur aTgII Master Curve Material