ADVIA Centaur aTPOII QC 11206985

GUDID 00630414608587

aTPOII ADVIA Centaur - CTL 2 x 3 x 1.0 mL

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

• Primary Device ID: 00630414608587
• NIH Device Record Key: 5abeeaa4-e2e7-4ed3-af3c-95a537737c19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur aTPOII QC
• Version Model Number: 11206985
• Catalog Number: 11206985
• Company DUNS: 296822794
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refridgerate; store upright
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage 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	00630414608587 [Primary]

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: 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

• 00630414608570 - ADVIA Centaur aTPOII: 2026-01-08 Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur - RGT 500T
• 00630414608587 - ADVIA Centaur aTPOII QC: 2026-01-08aTPOII ADVIA Centaur - CTL 2 x 3 x 1.0 mL
• 00630414608587 - ADVIA Centaur aTPOII QC: 2026-01-08 aTPOII ADVIA Centaur - CTL 2 x 3 x 1.0 mL
• 00630414608747 - ADVIA Centaur aTPOII: 2026-01-08 Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur - RGT 100T
• 00630414609409 - ADVIA Centaur aTPOII Diluent: 2026-01-08 aTPOII ADVIA Centaur - Diluent 2 x 5.0 mL
• 00630414238401 - Atellica IM Thyroglobulin (Tg): 2025-09-30 Atellica IM Thyroglobulin (Tg) MCM Set
• 00630414238418 - Atellica IM Tg: 2025-09-30 Thryoglobulin (Tg) - Atellica IM - RGT - 100T
• 00630414238425 - Atellica IM Tg: 2025-09-30 Thyroglobulin (Tg) - Atellica IM - RGT - 500T
• 00630414637877 - Atellica IM HBcT2: 2024-05-06 Atellica IM HBcT2 (REF) 500T