ADVIA Centaur® HBcT2 10376698

GUDID 00630414561226

ADVIA Centaur® HBcT2

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

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• Primary Device ID: 00630414561226
• NIH Device Record Key: 7f90eea5-5499-418c-acd8-9a9be0895fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur® HBcT2
• Version Model Number: 10376698
• Catalog Number: 10376698
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, protect from light, do not freeze, and resuspend.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414561226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210019

FDA Product Code

• LOM: Test, hepatitis b (b core, be antigen, be antibody, b core igm)

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: 2023-06-28
• Device Publish Date: 2023-06-20

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• 00630414210766 - ADVIA Centaur® HBcT2 Quality Control Kit: 2023-06-28 ADVIA Centaur® HBcT2
• 00630414604138 - Atellica IM HBcT2: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - RGT 100T
• 00630414604336 - Atellica IM HBcT2 QC: 2023-06-28 HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
• 00630414000138 - IMMULITE 2000 rBet v 2 Specific Allergen: 2022-09-20 rBet v 2 Alleren
• 00630414006246 - IMMULITE 2000 rMal d 1 Specific Allergen: 2022-09-20 rMal d 1 Allergen
• 00630414006253 - IMMULITE 2000 rPru av 3 Specific Allergen: 2022-09-20 rPru av 3 Allergen
• 00630414006277 - IMMULITE 2000 rPru av 4 Specific Allergen: 2022-09-20 rPru av 4 Allergen